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
4489–4512 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 18d
Cleared Jun 15, 1987
CIPRO (TM) DIAGNOSTIC POWDER
K872081 · JTT
Miles Pharmaceuticals
Microbiology · 17d
Cleared Jun 15, 1987
MCBRIDE MEDIUM CM 819
K872135 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 12d
Cleared Jun 10, 1987
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · JTL
Oxoid U.S.A., Inc.
Microbiology · 93d
Cleared Jun 10, 1987
ORICULT-N CULTURE-PADDLE
K872058 · JSI
Orion Corp.
Microbiology · 13d
Cleared Jun 04, 1987
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · GOD
Orion Diagnostica, Inc.
Microbiology · 191d
Cleared Jun 04, 1987
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
K870814 · GQL
Microscan Div. Baxter Healthcare Corp.
Microbiology · 93d
Cleared Jun 02, 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 7d
Cleared May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · LIO
Bio-Rad
Microbiology · 16d
Cleared May 29, 1987
MICROLAB AT
K871945 · JTC
Hamilton Co.
Microbiology · 10d
Cleared May 28, 1987
SYPHILIS SEROLOGICAL REAGENTS
K871226 · GMQ
New Horizons Diagnostics Co.
Microbiology · 62d
Cleared May 28, 1987
LD PRESUMPTO QUAD
K871907 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared May 26, 1987
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
K870733 · GQN
Enzo Biochem, Inc.
Microbiology · 90d
Cleared May 26, 1987
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
K871855 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 13d
Cleared May 21, 1987
GBNA MEDIUM
K871786 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared May 20, 1987
ARYLSULFATASE BROTH
K871701 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 20, 1987
MRS AGAR AND MRS BROTH
K871702 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 15, 1987
CELL LIFTER
K871559 · LIB
Corning Costar Corp.
Microbiology · 23d
Cleared May 15, 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · JTN
Organon Teknika Corp.
Microbiology · 16d
Cleared May 15, 1987
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
K871709 · KZJ
Difco Laboratories, Inc.
Microbiology · 14d
Cleared May 13, 1987
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
K871105 · LIC
New Horizons Diagnostics Co.
Microbiology · 55d
Cleared May 13, 1987
TODD HEWITT W/CNA (LIM BROTH)
K871447 · JSD
Remel Co.
Microbiology · 30d
Cleared May 13, 1987
ALKALINE PEPTONE WATER
K871640 · JSD
Bd Becton Dickinson Vacutainer...
Microbiology · 16d
Cleared May 08, 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · GQN
Boots-Celltech Diagnostics, Inc.
Microbiology · 86d