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
3673–3696 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 20, 1990
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.
K901397 · MCC
Gen-Probe, Inc.
Microbiology · 86d
Cleared Jun 20, 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · JTO
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jun 20, 1990
MICROMATE 196 MODEL A961960
K901808 · JTC
Packard Instrument Co., Inc.
Microbiology · 61d
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · LJC
Eastman Kodak Company
Microbiology · 51d
Cleared Jun 18, 1990
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · JWX
Orthomet, Inc.
Microbiology · 28d
Cleared Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
K900546 · GTH
Baxter Healthcare Corp
Microbiology · 130d
Cleared Jun 15, 1990
ZEFAZONE SUSCEPTIBILITY TEST DISKS
K902082 · JTN
Difco Laboratories, Inc.
Microbiology · 38d
Cleared Jun 01, 1990
PATHODX PYR KIT
K902037 · JTO
Diagnostic Products Corp.
Microbiology · 28d
Cleared May 21, 1990
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
K901243 · LJP
Cel Labs Pty, Ltd.
Microbiology · 67d
Cleared May 15, 1990
CELLOGNOST SYPHILIS H
K896410 · GMT
Behring Diagnostics, Inc.
Microbiology · 189d
Cleared May 15, 1990
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
K900688 · LFY
Clinical Sciences, Inc.
Microbiology · 91d
Cleared May 15, 1990
VISUWELL(R) CHLAMYDIA
K900973 · LJC
Adi Diagnostics, Inc.
Microbiology · 74d
Cleared May 15, 1990
ASO-CUBE(TM)
K901371 · GTQ
Difco Laboratories, Inc.
Microbiology · 53d
Cleared May 15, 1990
TROBICIN SUSCEPTIBILITY POWDER
K902004 · LOP
The Upjohn Co.
Microbiology · 39d
Cleared May 11, 1990
HERPTRAN CONCENTRATE
K900713 · LGC
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 86d
Cleared May 11, 1990
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · JSP
Vitek Systems, Inc.
Microbiology · 70d
Cleared May 11, 1990
TESTPACK PLUS STREP A
K901274 · GTZ
Abbott Laboratories
Microbiology · 53d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · LJC
Abbott Laboratories
Microbiology · 87d
Cleared May 02, 1990
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K897078 · LQF
Gen-Probe, Inc.
Microbiology · 131d
Cleared May 02, 1990
LYME IGM ELISA TEST SYSTEM
K900196 · LSR
Zeus Scientific, Inc.
Microbiology · 106d
Cleared May 02, 1990
LYME IGM MICROASSAY
K900572 · LSR
Diamedix Corp.
Microbiology · 84d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796 · LFZ
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Apr 30, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · LGD
Vitek Systems, Inc.
Microbiology · 68d
Cleared Apr 26, 1990
CMV-IGM IFA TEST SYSTEM
K900743 · LKQ
Zeus Scientific, Inc.
Microbiology · 69d