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
985–1008 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared May 02, 2014
FILMARRAY GASTROINTESTINAL (GI) PANEL
K140407 · PCH
Biofire Diagnostics
Microbiology · 73d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME...
K140857 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 25, 2014
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR...
K140851 · OEP
Centers For Disease Control and...
Microbiology · 22d
Not Cleared Apr 16, 2014
LYRA DIRECT STREP ASSAY
DEN140005 · PGX
Quidel Corporation
Microbiology · 22d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · OZN
QIAGEN GmbH
Microbiology · 102d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · OQO
Quidel Corporation
Microbiology · 79d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL...
K133673 · OZZ
Meridian Bioscience, Inc.
Microbiology · 116d
Not Cleared Mar 21, 2014
SIMPLEXA HSV 1&2 DIRECT
DEN130049 · PGH
Focus Diagnostics
Microbiology · 116d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · LFZ
Roche Diagnostics
Microbiology · 270d