Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
985–1008 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Dec 19, 2014
artus HSV-1/2 QS-RGQ MDx Kit
K142738 · OQO
Qiagen
Microbiology · 87d
Cleared Dec 17, 2014
cobas MRSA/SA Test
K142721 · NQX
Roche Molecular Systems, Inc.
Microbiology · 85d
Cleared Dec 16, 2014
SOFIA (R) STREP A+ FIA
K141775 · GTY
Quidel Corporation
Microbiology · 168d
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 CT 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 CT 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 CT 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