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
4945–4968 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 18, 1985
TRYPTIC SOY BLOOD AGAR
K854454 · KZI
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Nov 18, 1985
CDC ANAEROBE BLOOD AGAR
K854455 · JSG
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Nov 18, 1985
CAMPYLOBACTER BLOOD AGAR
K854456 · JSJ
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Nov 18, 1985
COLUMBIA CNA AGAR W/5% SHEEP BLOOD
K854457 · JSJ
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Nov 14, 1985
CMV TEST
K853137 · GQI
Gull Laboratories, Inc.
Microbiology · 111d
Cleared Nov 14, 1985
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL
K854097 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR PSEUDOMONAS PLUS MIC PANEL
K854098 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL
K854099 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM POSITIVE MIC/ID PANEL
K854100 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM POSITIVE MIC PANEL
K854101 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR ENTERIC MIC PANEL
K854102 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR ENTERIC MIC/ID PANEL
K854103 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 12, 1985
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
K852929 · GQI
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
K852930 · GQX
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
K852931 · GQO
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · LIQ
Armkel, LLC
Microbiology · 92d
Cleared Nov 12, 1985
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 35d
Cleared Nov 12, 1985
MEBIASIS AGAR GEL DIFFUSION KIT
K854230 · KHW
Lmd Laboratories
Microbiology · 22d
Cleared Nov 12, 1985
THAYER-MARTIN MEDIUM (MOD)
K854275 · JTY
R. Kent Richards, Inc.
Microbiology · 25d
Cleared Nov 07, 1985
ECHO TYPE 16 CF ANTIGEN
K853156 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
ECHO TYPE 11 CF ANTIGEN
K853157 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
ECHO TYPE 30 CF ANTIGEN
K853165 · GNK
Hillcrest Biologicals
Microbiology · 100d
Cleared Nov 07, 1985
CMV CF ANTIGEN
K853277 · GQI
Hillcrest Biologicals
Microbiology · 94d
Cleared Nov 07, 1985
POLIO TYPE I CF ANTIGEN, & TYPE II, III
K853278 · GOG
Hillcrest Biologicals
Microbiology · 94d