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
6961–6984 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527 · GMI
I M, Inc.
Microbiology · 364d
Cleared Mar 17, 1978
URINE SCREENING KITS
K780021 · JXA
Diagnostic Culture System
Microbiology · 72d
Cleared Mar 17, 1978
LYOPHILIZED VIALS OF VCA AND VCAT
K780306 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN
K780272 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM
K780273 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM
K780274 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN A/USSR
K780275 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM A/TEXAS
K780276 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM A/TEXAS
K780277 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 23, 1978
T3 STI KIT
K780146 · KHQ
Polysciences, Inc.
Microbiology · 24d
Cleared Feb 13, 1978
ANASWAB
K780159 · JTX
Scott Laboratories, Inc.
Microbiology · 14d
Cleared Feb 13, 1978
TOBRAMYCIN 125I RIA KIT
K780182 · DID
New England Nuclear
Microbiology · 10d
Cleared Jan 31, 1978
TILL-U=TEST
K780109 · JXA
Clinifax Industries, Ltd.
Microbiology · 12d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780004 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780005 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780006 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780007 · GQQ
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780008 · GQT
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-RUBELLA ANTISERA
K780010 · GOK
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
CULTURE MEDIA/ISOLA. PATHO. NEISSERIA
K780022 · JTY
Diagnostic Culture System
Microbiology · 16d
Cleared Jan 20, 1978
RUBENOSTICON
K780063 · GOK
Organon, Inc.
Microbiology · 8d
Cleared Jan 05, 1978
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
K772345 · DCB
Kallestad Laboratories, Inc.
Microbiology · 13d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., SINGLE WET
K772207 · JTW
Precision Dynamics Corp.
Microbiology · 19d
Cleared Dec 20, 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
K772209 · JTW
Precision Dynamics Corp.
Microbiology · 19d