FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
3625–3648 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 16, 1990
CHLAMYDIA ACCU-CULSHURE TM
K903405 · LIO
Medical Laboratory Automation...
Microbiology · 77d
Cleared Oct 16, 1990
VIRAL ACCU-CULSHURE TM
K903406 · LIO
Medical Laboratory Automation...
Microbiology · 77d
Cleared Oct 16, 1990
EBV/EA-CHECK TM TEST KIT
K903612 · LSE
Diagnostic Technology, Inc.
Microbiology · 68d
Cleared Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · LIN
Baxter Healthcare Corp
Microbiology · 41d
Cleared Oct 16, 1990
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · LYF
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Oct 04, 1990
CYSTICERCOSIS SEROLOGICAL REAGENTS
K900780 · MDJ
Lmd Laboratories
Microbiology · 226d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · GTY
Hybritech, Inc.
Microbiology · 86d
Cleared Oct 02, 1990
CATARRHALIS TEST STRIP
K902595 · JTO
Remel Co.
Microbiology · 112d
Cleared Oct 02, 1990
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST
K903556 · MDE
Gen-Probe, Inc.
Microbiology · 56d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765 · LJC
Quidel Corp.
Microbiology · 46d
Cleared Oct 02, 1990
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.
K904047 · MDF
Gen-Probe, Inc.
Microbiology · 28d
Cleared Sep 17, 1990
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · LGC
Eastman Kodak Company
Microbiology · 27d
Cleared Sep 12, 1990
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156 · GNP
Granbio, Inc.
Microbiology · 183d
Cleared Sep 12, 1990
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
K901840 · LJN
Granbio, Inc.
Microbiology · 141d
Cleared Sep 12, 1990
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST
K903201 · MDC
Gen-Probe, Inc.
Microbiology · 54d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · LJC
Syva Co.
Microbiology · 23d
Cleared Sep 10, 1990
MODIFICATION TO API UNISCEPT 20GP
K901559 · LQL
Analytical Products, Inc.
Microbiology · 160d
Cleared Sep 10, 1990
DIRECTIGEN FLU A
K902609 · GNT
Bd Becton Dickinson Vacutainer...
Microbiology · 90d
Cleared Sep 05, 1990
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
K901972 · LJC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 127d
Cleared Sep 05, 1990
MODIFICATION OF SEROCARD RUBELLA IGG TEST
K902571 · LFX
Disease Detection International, Inc.
Microbiology · 90d
Cleared Aug 23, 1990
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
K896494 · LQF
Gen-Probe, Inc.
Microbiology · 283d
Cleared Aug 23, 1990
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
K897077 · LQF
Gen-Probe, Inc.
Microbiology · 244d
Cleared Aug 22, 1990
FLORA-STAT URINE TRANSPORT SYSTEM
K902467 · LIO
Wadley Biosciences Corp.
Microbiology · 79d
Cleared Aug 22, 1990
REDITEST STREP A TEST KIT
K903194 · GTZ
Boehringer Mannheim Corp.
Microbiology · 34d