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
961–984 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 10, 2014
AmpliVue Bordetella Assay
K143206 · OZZ
Quidel Corporation
Microbiology · 33d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · MDB
Becton, Dickinson and Company
Microbiology · 156d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 05, 2014
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
K142365 · OCC
Focus Diagnostics
Microbiology · 102d
Cleared Nov 26, 2014
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert...
K142501 · PCH
Cepheid
Microbiology · 82d
Cleared Nov 22, 2014
XPERT FLU/RSV XC ASSAY
K142045 · OCC
Cepheid
Microbiology · 117d
Cleared Nov 14, 2014
CL DETECT RAPID TEST
K141341 · PIT
InBios International, Inc.
Microbiology · 177d
Cleared Nov 04, 2014
LIAT STREP A ASSAY
K141338 · PGX
Iquum, Inc.
Microbiology · 167d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170 · LON
Becton, Dickinson and Company
Microbiology · 82d
Cleared Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
K142133 · LFZ
Roche Diagnostics
Microbiology · 81d
Cleared Oct 24, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140647 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 225d
Cleared Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · JWY
Thermo Fisher Scientific
Microbiology · 123d
Cleared Oct 10, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
K142033 · PCH
Nanospere,Inc.
Microbiology · 77d
Cleared Oct 10, 2014
MECA XPRESSFISH
K140619 · MYI
Advandx, Inc.
Microbiology · 213d
Cleared Oct 09, 2014
LYRA ADENOVIRUS ASSAY
K141931 · OCC
Quidel Corporation
Microbiology · 85d
Cleared Oct 09, 2014
LYRA PARAINFLUENZA VIRUS ASSAY
K141927 · OOU
Quidel Corporation
Microbiology · 85d
Not Cleared Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
DEN140019 · PII
T2biosystems, Inc.
Microbiology · 118d
Cleared Sep 16, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140377 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 214d
Cleared Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851 · MYI
Alere Scarborough, Inc.
Microbiology · 258d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · JJX
Siemens Healthcare Diagnostics, Inc.
Microbiology · 49d
Cleared Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
K133952 · NGZ
bioMerieux, Inc.
Microbiology · 239d
Cleared Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
K133817 · NGZ
bioMerieux, Inc.
Microbiology · 232d
Cleared Aug 01, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5...
K141859 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · JWY
Thermo Fisher Scientific
Microbiology · 226d