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
4273–4296 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 05, 1988
PROSPECT/GIARDIA
K874849 · KHW
Alexon Biomedical, Inc.
Microbiology · 41d
Cleared Jan 05, 1988
MUG-INDOLE DISC
K874933 · JTO
Scott Laboratories, Inc.
Microbiology · 32d
Cleared Dec 29, 1987
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
K874878 · LSK
Gen-Probe, Inc.
Microbiology · 29d
Cleared Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628 · LSL
Ortho Diagnostic Systems, Inc.
Microbiology · 168d
Cleared Dec 11, 1987
HERPES 1 AND 2 MICROASSAYS
K871420 · GGC
Diamedix Corp.
Microbiology · 247d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · LIQ
Abbott Laboratories
Microbiology · 45d
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078 · LIC
Meridian Diagnostics, Inc.
Microbiology · 64d
Cleared Dec 09, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · JWY
Analytical Products, Inc.
Microbiology · 37d
Cleared Dec 07, 1987
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
K874259 · JWZ
California Integrated Diagnostics, Inc.
Microbiology · 48d
Cleared Dec 04, 1987
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
K872576 · GQH
Enzo Biochem, Inc.
Microbiology · 157d
Cleared Dec 04, 1987
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
K874174 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
K874175 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
BIOTIS (TM) BCYE
K874177 · KZI
Otisville Biopharm, Inc.
Microbiology · 50d
Cleared Dec 04, 1987
BIOTIS (TM) BCYE SELECTIVE
K874178 · JSJ
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 02, 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Nov 27, 1987
ROTASCREEN EIA
K873740 · LIQ
Mercia Diagnostics , Ltd.
Microbiology · 73d
Cleared Nov 24, 1987
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
K874456 · LIO
Tm & M C/O Burditt,Bowles,Radzius &...
Microbiology · 27d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904 · GTZ
Binax, Inc.
Microbiology · 119d
Cleared Nov 20, 1987
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
K873564 · LKT
Genetic Systems Corp.
Microbiology · 79d
Cleared Nov 20, 1987
THE EXTRACTOR(TM)
K873932 · DKO
Molecular Biosystems, Inc.
Microbiology · 56d
Cleared Nov 20, 1987
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · JTN
Organon Teknika Corp.
Microbiology · 31d
Cleared Nov 20, 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 23d
Cleared Nov 20, 1987
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537 · JSE
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 20, 1987
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 17d