FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5928 Microbiology devices
1826–1850 of 5928
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · Dade Behring, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 35d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
K020686 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 57d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 53d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 65d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 59d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · bioMerieux, Inc.
MDB · System, Blood Culturing · 18d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)
K020397 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 75d
Cleared Apr 19, 2002
BACTEC MGIT 960 SIRE KITS
K014123 · Becton, Dickinson & CO
MJA · Susceptibility Test Powders, Antimycobacterial · 123d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · bioMerieux, Inc.
MDB · System, Blood Culturing · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · bioMerieux, Inc.
MDB · System, Blood Culturing · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · bioMerieux, Inc.
MDB · System, Blood Culturing · 27d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
K020319 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 77d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
K020506 · Dade Microscan, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · bioMerieux, Inc.
MDB · System, Blood Culturing · 35d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 79d
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · Oxoid , Ltd.
MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies · 302d
Cleared Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 91d
Cleared Mar 27, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 71d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 48d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS
K020142 · Dade Behring, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d

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All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74