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
4681–4704 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT PET-RPLA
K855235 · JSP
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT TST-RPLA
K855236 · GTN
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Oct 31, 1986
CANDIDA BROM CRESOL GREEN AGAR
K864077 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 11d
Cleared Oct 31, 1986
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · JTY
Bd Becton Dickinson Vacutainer...
Microbiology · 11d
Cleared Oct 31, 1986
TRYCOPHYTON AGARS
K864100 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 10d
Cleared Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · LIQ
Wellcome Diagnostics
Microbiology · 183d
Cleared Oct 29, 1986
LOMBARD DOWELL AGAR BASE
K864014 · KZI
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 82d
Cleared Oct 17, 1986
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
K862948 · LJC
Intercare Diagnostics, Inc.
Microbiology · 73d
Cleared Oct 10, 1986
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · JSM
Kallestad Laboratories, Inc.
Microbiology · 21d
Cleared Oct 09, 1986
AMEBIASIS MICROASSAY
K863811 · KHW
Diamedix Corp.
Microbiology · 9d
Cleared Oct 09, 1986
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Oct 08, 1986
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
K863820 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 8d
Cleared Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · GQI
Labsystems, Inc.
Microbiology · 77d
Cleared Sep 30, 1986
COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
K862814 · LQP
Institute Virion , Ltd.
Microbiology · 68d
Cleared Sep 30, 1986
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · LQL
American Micro Scan
Microbiology · 49d
Cleared Sep 30, 1986
XANTHINE/TYROSINE/CASEIN AGAR
K863572 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Sep 30, 1986
BIRD SEED AGAR
K863573 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Sep 30, 1986
STARCH AGAR W/BROM CRESOL PURPLE
K863599 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
K863600 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
ONPG SOLUTION
K863601 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
BUFFERED GLYCEROL SALINE
K863602 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
GI MOTILITY TEST MEDIUM W/TTC
K863603 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 29, 1986
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
K862354 · LJP
Synbiotics Corp.
Microbiology · 101d