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
4009–4032 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 30, 1988
ON THE SPOT CANDIDASURE
K883118 · LRF
Medi-Tech, Inc.
Microbiology · 67d
Cleared Sep 28, 1988
HERPES VIRUS CONTROL SLIDES
K883684 · GQN
Val Tech Diagnostics, Inc.
Microbiology · 30d
Cleared Sep 28, 1988
IMMUNO/FEBRILE ANTIGENS
K883685 · GNC
Immunostics Co., Inc.
Microbiology · 30d
Cleared Sep 27, 1988
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325
K883551 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 39d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323
K883548 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC PANEL #80322
K883549 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STAPHYLOCOCCUS MIC #80324
K883550 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328
K883552 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331
K883553 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329
K883554 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332
K883555 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 16, 1988
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · JSS
Vitek Systems, Inc.
Microbiology · 28d
Cleared Sep 08, 1988
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
K882477 · JWY
Pasco Laboratories, Inc.
Microbiology · 86d
Cleared Sep 07, 1988
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
K883076 · JWY
Baxter Healthcare Corp
Microbiology · 56d
Cleared Sep 07, 1988
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
K883385 · JXA
Los Alamos Diagnostics
Microbiology · 29d
Cleared Sep 07, 1988
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K883394 · JWY
Baxter Healthcare Corp
Microbiology · 27d
Cleared Sep 02, 1988
PHADEBACT ETEC-LT TEST
K874288 · GNA
Pharmacia, Inc.
Microbiology · 318d
Cleared Aug 30, 1988
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K875203 · LLM
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 256d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883 · GNP
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · LJN
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885 · GNP
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · LJN
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · LKT
Gull Laboratories, Inc.
Microbiology · 61d
Cleared Aug 29, 1988
PHARMACIA CHLAMYDIA EIA
K882676 · LJC
Pharmacia, Inc.
Microbiology · 62d