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
5881–5904 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 22, 1983
INDIRECT FLUORESCENT ANTIBODY REAGENTS
K831026 · LHL
Zeus Technologies
Microbiology · 84d
Cleared Jun 22, 1983
RIM BETA LACTAMASE TEST
K831654 · JTO
Austin Biological Laboratories
Microbiology · 30d
Cleared Jun 22, 1983
SPECTRUM-10
K831672 · JSS
Austin Biological Laboratories
Microbiology · 30d
Cleared Jun 17, 1983
SPECTRUM-10
K831655 · JSZ
Austin Biological Laboratories
Microbiology · 25d
Cleared Jun 16, 1983
RAPID IDENTIFI-METHOD NEISSERIA KIT
K830968 · JTO
Austin Biological Laboratories
Microbiology · 80d
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · DBM
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jun 12, 1983
URINE SCREENING KIT
K830824 · CEN
Syn-Kit, Inc.
Microbiology · 89d
Cleared Jun 08, 1983
DATA-ZYME ALKALINE PHOSPHATASE PROCED
K831360 · CJE
Data Medical Associates, Inc.
Microbiology · 43d
Cleared Jun 08, 1983
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
K831469 · JSK
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Jun 08, 1983
LA-STAPH IDENTIFICATION SYSTEM
K831918 · JWX
Immuno-Mycologics, Inc.
Microbiology
Cleared Jun 02, 1983
BETA-PREG
K831361 · JHJ
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
TESTCORP ANA
K831365 · LKS
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
TESTCORP PREG
K831366 · JHJ
Catheter Technology Corp.
Microbiology · 37d
Cleared May 27, 1983
DIRECTIGEN NEISSERIA MENINGITIDIS
K830646
Bd Becton Dickinson Vacutainer...
Microbiology · 87d
Cleared May 27, 1983
TESTCORP CRP
K831362 · DCN
Catheter Technology Corp.
Microbiology · 31d
Cleared May 27, 1983
TESTCORP RA
K831364 · DCN
Myo-Tronics Research, Inc.
Microbiology · 31d
Cleared May 25, 1983
MYCOPLASMELISA TEST KIT
K823804 · LJZ
M.A. Bioproducts
Microbiology · 159d
Cleared May 25, 1983
BERA SH 221 BRIAN STEM AUDIOMETER
K830173 · GNJ
Jedmed Instrument Co.
Microbiology · 127d
Cleared May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · JTT
Miles Laboratories, Inc.
Microbiology · 76d
Cleared May 18, 1983
API 20GP
K830525 · JSE
Analytical Products, Inc.
Microbiology · 90d
Cleared May 18, 1983
MODIFIED NEW YORK MEDIUM
K831359 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared May 16, 1983
STREPTOCOCUS ID PLATE
K831349 · JST
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared May 16, 1983
TESTCORP ASO
K831363 · GTQ
Catheter Technology Corp.
Microbiology · 20d
Cleared May 13, 1983
MUMPSELISA TEST KIT
K830045 · LJY
M.A. Bioproducts
Microbiology · 123d