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
150d
Avg (2y)
1976
Since
5945 Microbiology devices
5726–5750 of 5945
Cleared Sep 24, 1979
TRYPTIC SOY AGAR 5% SHEEP BLOOD
K791620 · American Laboratory Supply, Inc.
JSG · Culture Media, Non-selective And Non-differential · 34d
Cleared Sep 24, 1979
MANNITOL SALT AGAR
K791621 · American Laboratory Supply, Inc.
JSI · Culture Media, Selective And Differential · 34d
Cleared Sep 24, 1979
COLUMBIA AGAR WITH5% SHEEP
K791622 · American Laboratory Supply, Inc.
JSG · Culture Media, Non-selective And Non-differential · 34d
Cleared Sep 24, 1979
MUELLER-HINTON AGAR
K791624 · American Laboratory Supply, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 34d
Cleared Sep 17, 1979
MODIFIED THAYER-MARTIN AGAR (PLATE)
K791425 · American Laboratory Supply, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 53d
Cleared Sep 17, 1979
MARTIN LEWIS JEMBEC CSI 8872
K791446 · Clinical Sciences, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 48d
Cleared Sep 17, 1979
MARTIN LEWIS AGAR CSI 3169
K791447 · Clinical Sciences, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 48d
Cleared Sep 17, 1979
THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR
K791542 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 38d
Cleared Sep 17, 1979
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
K791543 · Isle Media and Sterile Products, Inc.
JSM · Culture Media, Non-propagating Transport · 38d
Cleared Sep 17, 1979
TRYPTIC SOY AGAR WITH SHEEP BLOOD
K791544 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 38d
Cleared Sep 17, 1979
TRANSPORT MEDIUM AMIES
K791545 · Isle Media and Sterile Products, Inc.
JSM · Culture Media, Non-propagating Transport · 38d
Cleared Sep 17, 1979
COLUMBIA CNA BLOOD AGAR
K791546 · Isle Media and Sterile Products, Inc.
JSR · Kit, Identification, Dermatophyte · 38d
Cleared Sep 17, 1979
CHOCOLATE AGAR
K791553 · American Laboratory Supply, Inc.
JSG · Culture Media, Non-selective And Non-differential · 31d
Cleared Sep 17, 1979
TRANSGROW
K791554 · American Laboratory Supply, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 31d
Cleared Sep 17, 1979
LEVINE EOSIN METHYLER
K791555 · American Laboratory Supply, Inc.
JSI · Culture Media, Selective And Differential · 31d
Cleared Sep 17, 1979
MACCONKEY AGAR (PLATE)
K791556 · American Laboratory Supply, Inc.
JSH · Culture Media, Non-selective And Differential · 31d
Cleared Sep 17, 1979
MARTIN-LEWIS AGAR (PLATE)
K791557 · American Laboratory Supply, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 31d
Cleared Sep 17, 1979
ANAEROBIC BRUCELLA BLOOD AGAR
K791562 · Anaerobe Systems
JSG · Culture Media, Non-selective And Non-differential · 34d
Cleared Sep 17, 1979
ANAEROBIC BRUCELLA LAKED BLOOD AGAR
K791563 · Anaerobe Systems
JSI · Culture Media, Selective And Differential · 34d
Cleared Sep 17, 1979
ANAEROBIC BRUCELLA BLOOD AGAR
K791579 · Anaerobe Systems
JSI · Culture Media, Selective And Differential · 31d
Cleared Sep 17, 1979
G N BROTH HAJNA
K791589 · Isle Media and Sterile Products, Inc.
JSD · Culture Media, Selective Broth · 34d
Cleared Sep 17, 1979
PHENYLALANINE AGAR
K791590 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 34d
Cleared Sep 17, 1979
MOTILITY TEST MEDIUM
K791591 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 34d
Cleared Sep 17, 1979
BRILLIANT GREEN BILE 2%
K791592 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 34d
Cleared Sep 17, 1979
BRILLIANT GREEN AGAR
K791593 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 34d

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All categories 5945 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 99 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 75