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
5931 Microbiology devices
2426–2450 of 5931
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · Unipath , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · Unipath , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · Unipath , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 90d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · Unipath , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 90d
Cleared Feb 06, 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · Microbiologics, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 35d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · Bio-Rad Laboratories, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 340d
Cleared Feb 04, 1997
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · Becton Dickinson Microbiology Systems
LQL · Gram Positive Identification Panel · 277d
Cleared Feb 04, 1997
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LQL · Gram Positive Identification Panel · 260d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · Armkel, LLC
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 145d
Cleared Feb 04, 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864 · Alexon Biomedical, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 62d
Cleared Feb 04, 1997
MINK LUNG CELL CULTURE
K965047 · Neogenex
KIR · Cells, Animal And Human, Cultured · 48d
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675 · Pyramid Biological Corp.
LYR · Helicobacter Pylori · 67d
Cleared Jan 22, 1997
SERAQUEST HSV IGG
K963282 · Quest Intl., Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 154d
Cleared Jan 22, 1997
A.C.T. I
K965149 · Remel Co.
JSM · Culture Media, Non-propagating Transport · 30d
Cleared Jan 22, 1997
A.C.T. IV
K965150 · Remel Co.
JSM · Culture Media, Non-propagating Transport · 30d
Cleared Jan 22, 1997
A.C.T. III
K965151 · Remel Co.
JSM · Culture Media, Non-propagating Transport · 30d
Cleared Jan 22, 1997
A.C.T. II
K965152 · Remel Co.
JSM · Culture Media, Non-propagating Transport · 30d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc.
LYR · Helicobacter Pylori · 277d
Cleared Jan 15, 1997
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 63d
Cleared Dec 26, 1996
IMAGEN RESPIRATORY SCREEN
K962037 · Dako Diagnostics , Ltd.
GNW · Antisera, Cf, Influenza Virus A, B, C · 216d
Cleared Dec 24, 1996
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
K964637 · Medical Packaging Corp.
JSM · Culture Media, Non-propagating Transport · 35d
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 554d
Cleared Dec 18, 1996
STREPTOCOCCUS MIC PANEL
K963641 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 97d
Cleared Dec 18, 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Dec 16, 1996
STREPTOLEX-STAT
K962296 · Unipath , Ltd.
GTZ · Antisera, All Groups, Streptococcus Spp. · 187d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

All categories 5931 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 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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75