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
1009–1032 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jul 25, 2014
LIAISON XL ANALYZER
K141116 · LOL
DiaSorin, Inc.
Microbiology · 86d
Cleared Jul 24, 2014
AMPLIVUE GAS ASSAY
K141173 · PGX
Quidel Corporation
Microbiology · 79d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Jul 01, 2014
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
K141458 · PGH
Focus Diagnostics
Microbiology · 29d
Cleared Jun 30, 2014
MUELLER HINTON AGAR
K132491 · JTZ
Edge Biologicals, Inc.
Microbiology · 326d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jun 20, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
K140083 · PCH
Nanosphere, Inc.
Microbiology · 158d
Cleared Jun 13, 2014
ALERE I INFLUENZA A & B
K141520 · OCC
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 4d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · JWY
Thermo Fisher Scientific
Microbiology · 55d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · LON
Becton, Dickinson and Company
Microbiology · 97d
Cleared May 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220 · NSU
Thermo Fisher Scientific (Life...
Microbiology · 10d
Cleared May 22, 2014
CAPTIA MEASLES IGM
K140455 · PCL
Trinity Biotech USA
Microbiology · 87d
Cleared May 22, 2014
ANTHRACIS REAL-TIME PCR ASSAY
K140426 · NHT
Centers For Disease Control and...
Microbiology · 92d
Cleared May 20, 2014
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · LSL
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447 · OOI
Becton, Dickinson and Company
Microbiology · 88d
Cleared May 20, 2014
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · MKZ
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · OQO
Intelligent Medical Devices, Inc.
Microbiology · 106d
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · PGI
Diagnostic Hybrids, Inc.
Microbiology · 81d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · LSL
Abbott Molecular, Inc.
Microbiology · 86d
Cleared May 06, 2014
BD MAX(TM) ENTERIC BACTERIAL PANEL
K140111 · PCI
Becton, Dickinson and Company
Microbiology · 111d