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

5601–5625 of 5945

Cleared Mar 12, 1980

SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.

K792349 · Pfizer, Inc.

JNT · Chromatographic, Phospholipids · 114d

Cleared Mar 12, 1980

STERILE GC SUPPLEMENT

K800252 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

MYCOPLASMA SUPPLEMENT G

K800253 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

MYCOPLASMA SUPPLEMENT P

K800254 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

STERILE GC SUPPLEMENT (W/O ANTIBIOTICS)

K800255 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

TINSDALE SUPPLEMENT

K800256 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

CAMPYLOBACTER SELECTIVE SUPPLEMENT

K800257 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT

K800258 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT

K800259 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

STREPTOCOCCUS SUPPLEMENT

K800260 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

DERMASEL SUPPLEMENT

K800261 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

PERFRINGENS SUPPLEMENT A

K800262 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

PERFRINGENS SUPPLEMENT B

K800263 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT

K800264 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

BORDETELLA SELECTIVE SUPPLEMENT

K800265 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

CAMPYLOBACTER GROWTH SUPPLEMENT

K800266 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 12, 1980

CAMPYLOBACTER SELECTIVE SUPPLEMENT

K800267 · Oxoid U.S.A., Inc.

JSK · Supplement, Culture Media · 35d

Cleared Mar 03, 1980

NEISSERIA GONORRHOEAE FLUORO-KIT

K800328 · Clinical Sciences, Inc.

GTH · Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae · 20d

Cleared Mar 03, 1980

CAMPYLOBACTER AGAR, CAT. NO. P2536

K800329 · Gibco Laboratories Life Technologies, Inc.

JSJ · Culture Media, Selective And Non-differential · 19d

Cleared Mar 03, 1980

MODIFIED THAYER-MARTIN X AGAR

K800333 · Isle Media and Sterile Products, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 18d

Cleared Mar 03, 1980

MARTIN-LEWIS AGAR

K800334 · Isle Media and Sterile Products, Inc.

JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 18d

Cleared Feb 13, 1980

STAPHYLOCOCCUS MED. 110

K800156 · Isle Media and Sterile Products, Inc.

JSJ · Culture Media, Selective And Non-differential · 20d

Cleared Feb 13, 1980

BISMUTH SULFITE AGAR

K800157 · Isle Media and Sterile Products, Inc.

JSI · Culture Media, Selective And Differential · 20d

Cleared Feb 13, 1980

AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD

K800158 · Isle Media and Sterile Products, Inc.

JSJ · Culture Media, Selective And Non-differential · 20d

Cleared Jan 24, 1980

K792676 · Remel Co.

JSJ · Culture Media, Selective And Non-differential · 28d

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