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
6265–6288 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 03, 1981
SHIGELLA SERA-CHEK
K813191 · LIA
Lab Ability, Inc.
Microbiology · 16d
Cleared Dec 03, 1981
COOKED MEAT MEDIUM
K813232 · JSG
Oxoid U.S.A., Inc.
Microbiology · 16d
Cleared Nov 27, 1981
EIA RUBELLA
K812787 · LFX
Gilford
Microbiology · 53d
Cleared Nov 24, 1981
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM
K812885 · KIT
Dutchland Laboratories, Inc.
Microbiology · 41d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 85d
Cleared Nov 10, 1981
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK
K812993 · JTN
General Diagnostics
Microbiology · 15d
Cleared Nov 06, 1981
VDRL CARBON ANTIGEN
K812894 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 22d
Cleared Nov 06, 1981
BCYE MEDIUM
K812911 · JSE
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Nov 06, 1981
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
K812916 · JTN
General Diagnostics
Microbiology · 18d
Cleared Nov 06, 1981
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · DHR
Intl. Diagnostic Technology
Microbiology · 15d
Cleared Nov 06, 1981
RA LATEX TEST
K812972 · DHR
Oxoid U.S.A., Inc.
Microbiology · 14d
Cleared Nov 05, 1981
HERPES
K811021 · GQN
Immuno-Diagnostic Products, Inc.
Microbiology · 204d
Cleared Oct 28, 1981
MOXALACTAM 30 MCG. SENSITIVITY DISCS
K812228 · JTN
Difco Laboratories, Inc.
Microbiology · 79d
Cleared Oct 26, 1981
IDS PORPHYRIN REAGENT
K812859 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
IMMUNOASSAY PLATE
K812860 · JTC
Skatron, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
API GERM TUBE
K812862 · JTO
Analytab Products, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
RHEUMATEX
K812882 · DHR
Armkel, LLC
Microbiology · 12d
Cleared Oct 23, 1981
CELL CULTURE REAGENTS
K812531 · KIT
M.A. Bioproducts
Microbiology · 51d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 25d
Cleared Oct 23, 1981
REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
K812741 · LHK
Nolan Biological Laboratories, Inc.
Microbiology · 24d
Cleared Oct 23, 1981
TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK
K812783 · JTN
General Diagnostics
Microbiology · 18d
Cleared Oct 23, 1981
TITERTEK AUTODROP
K812818 · JTC
Flow Laboratories, Inc.
Microbiology · 16d
Cleared Oct 23, 1981
FORMA CH/P GAS PROCESSOR
K812826 · JTQ
Forma Scientific, Inc.
Microbiology · 15d
Cleared Oct 23, 1981
MOXALACTAM 30MCG. SENSI-DISC
K812844 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 14d