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

5926–5945 of 5945

Cleared Oct 29, 1976

K760790 · General Diagnostics

JSS · Kit, Identification, Enterobacteriaceae · 22d

Cleared Oct 07, 1976

IMPROVED THAYER MARTIN MEDIUM

K760588 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 34d

Cleared Oct 07, 1976

K760589 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JSK · Supplement, Culture Media · 34d

Cleared Oct 07, 1976

THAYER-MARTIN MEDIUM WITH ANSIOMYCIN

K760690 · Flow Laboratories, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 16d

Cleared Oct 07, 1976

THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L

K760691 · Flow Laboratories, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 16d

Cleared Oct 07, 1976

MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN

K760692 · Flow Laboratories, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 16d

Cleared Oct 07, 1976

NEIGON JEMBEC PLATE WITH ANIXOMYCIN

K760693 · Flow Laboratories, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 16d

Cleared Oct 03, 1976

DISPOSABLE/BOROSILICATE CULTURE TUBES

K760583 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Cleared Sep 03, 1976

SCHAEDLER-SELECTIVE AGAR CNA

K760457 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JSJ · Culture Media, Selective And Non-differential · 17d

Cleared Sep 03, 1976

BOTTLE, BLOOD CULTURE, SCHAEDLER

K760458 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTW · System, Transport, Aerobic · 17d

Cleared Sep 03, 1976

MUELLER HINTON AGAR W/HEMOGLOBIN

K760459 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JSG · Culture Media, Non-selective And Non-differential · 17d

Cleared Sep 03, 1976

SCHAEDLER SELECTIVE AGAR-KV

K760460 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JSJ · Culture Media, Selective And Non-differential · 17d

Cleared Aug 30, 1976

SLIDE, LAB-TEK COVERED MICRO

K760278 · Miles Laboratories, Inc.

KEW · Slides, Microscope · 38d

Cleared Aug 11, 1976

TEST, STREP, LATEX SLIDE

K760034 · Gamma Biologicals, Inc.

DEM · Alpha-1-antitrypsin, Antigen, Antiserum, Control · 58d

Cleared Aug 03, 1976

TEST, ANTIBODIES FOR GRP A, LATEX SLIDE

K760033 · Gamma Biologicals, Inc.

GTZ · Antisera, All Groups, Streptococcus Spp. · 50d

Cleared Aug 03, 1976

CULTURE TUBE, (VACUTAINER)

K760054 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTW · System, Transport, Aerobic · 48d

Cleared Aug 03, 1976

SPECIMEN COLLECTOR, ANAEROBIC

K760063 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTX · Transport Systems, Anaerobic · 48d

Cleared Aug 03, 1976

REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

K760096 · Gamma Biologicals, Inc.

GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 50d

Cleared Aug 03, 1976

FEBRILE ANTIGENS & CONTROL SERUMS

K760097 · Gamma Biologicals, Inc.

GSZ · Antigens, Febrile (weil-felix), All Groups · 50d

Cleared Aug 03, 1976

K760098 · Gamma Biologicals, Inc.

GMT · Antigens, Ha, Treponema Pallidum · 50d

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