FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1033–1056 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
K132468 · NQX
Elitechgroup Epoch Biosciences
Microbiology · 71d
Cleared Oct 17, 2013
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
K132251 · LSL
Hologic / Gen-Probe Incorporated
Microbiology · 90d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · LON
bioMerieux, Inc.
Microbiology · 115d
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010 · MCB
Biomerieux S.A.
Microbiology · 100d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · PSZ
Becton, Dickinson and Company
Microbiology · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · PSZ
Becton, Dickinson and Company
Microbiology · 25d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508 · OZE
Centers For Disease Control and...
Microbiology · 42d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · LON
bioMerieux, Inc.
Microbiology · 28d
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · PSZ
Princeton BioMeditech Corp.
Microbiology · 33d
Cleared Sep 06, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · OCC
Quidel Corp.
Microbiology · 78d
Cleared Aug 29, 2013
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · OZE
Quidel Corp.
Microbiology · 78d
Cleared Aug 28, 2013
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
K132234 · LGD
DiaSorin, Inc.
Microbiology · 41d
Cleared Aug 26, 2013
PROPARAFLU+ ASSAY
K132238 · OOU
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · OUY
Becton, Dickinson & CO
Microbiology · 200d
Cleared Aug 22, 2013
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352 · GNX
Sa Scientific , Ltd.
Microbiology · 24d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · OCC
Intelligent Medical Devices, Inc.
Microbiology · 82d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · PEX
bioMerieux, Inc.
Microbiology · 231d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 29d
Cleared Aug 14, 2013
PROADENO+ ASSAY
K132159 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 33d
Cleared Aug 13, 2013
SOFIA(R) RSV FIA
K130398 · GQG
Quidel Corp.
Microbiology · 175d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 30d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · LGD
DiaSorin, Inc.
Microbiology · 81d