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
889–912 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 448d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K152774 · JWY
Thermo Fisher Scientific
Microbiology · 87d
Cleared Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K152386 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 115d
Cleared Dec 09, 2015
ProParaFlu+ Assay
K153223 · OOU
Hologic, Inc.
Microbiology · 33d
Cleared Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K151226 · OCC
Cepheid
Microbiology · 210d
Cleared Dec 01, 2015
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5...
K153148 · OZE
Centers For Disease Control and...
Microbiology · 32d
Cleared Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
K152846 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
K152838 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Nov 20, 2015
ProFlu+ Assay
K153219 · OCC
Hologic, Inc.
Microbiology · 15d
Cleared Nov 12, 2015
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test...
K150358 · GMQ
Gold Standard Diagnostics
Microbiology · 273d
Cleared Nov 10, 2015
illumigene Pertussis DNA Amplification Assay
K152285 · OZZ
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
K152874 · PSZ
Becton, Dickinson and Co.
Microbiology · 27d
Cleared Oct 27, 2015
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
K152870 · PSZ
Becton, Dickinson and Co.
Microbiology · 27d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800 · OZX
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Oct 16, 2015
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx,...
K151565 · OUY
Cepheid
Microbiology · 128d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial...
K152516 · JTN
Becton, Dickinson and Company
Microbiology · 40d
Not Cleared Oct 08, 2015
FilmArray Meningitis/Encephalitis(ME) Panel
DEN150013 · PLO
Biofire Diagnostics, LLC
Microbiology · 182d
Cleared Oct 07, 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · JWY
Biomerieux S.A.
Microbiology · 90d
Cleared Oct 06, 2015
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay...
K151906 · PGI
Luminex Corporation
Microbiology · 85d
Cleared Oct 01, 2015
JBAIDS Influenza A & B Detection Kit
K152523 · OCC
U.S Army Medical Materiel Development...
Microbiology · 28d
Cleared Oct 01, 2015
hemoFISH Masterpanel
K150031 · JSS
Miacom Diagnostics GmbH
Microbiology · 266d
Cleared Sep 21, 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
K152408 · OCC
Focus Diagnostics, Inc.
Microbiology · 27d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · JWY
Beckman Coulter, Inc.
Microbiology · 27d
Cleared Sep 04, 2015
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
K143653 · OCC
Nanosphere, Inc.
Microbiology · 255d