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
913–936 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 11, 2016
chromID MRSA
K151688 · JSO
bioMerieux, Inc.
Microbiology · 262d
Cleared Mar 07, 2016
Xpert Carba-R
K152614 · PMY
Cepheid
Microbiology · 175d
Cleared Feb 25, 2016
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · PSZ
Becton, Dickinson & CO
Microbiology · 29d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · MDB
Becton, Dickinson and Company
Microbiology · 231d
Cleared Feb 24, 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · PSZ
Becton, Dickinson & CO
Microbiology · 28d
Not Cleared Feb 20, 2016
B.R.A.H.M.S PCT sensitive KRYPTOR
DEN150009 · PMT
Brahms GmbH
Microbiology · 353d
Cleared Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
K151817 · NGZ
bioMerieux, Inc.
Microbiology · 227d
Cleared Feb 08, 2016
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
K160068 · OCC
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · LON
Becton, Dickinson and Company
Microbiology · 242d
Cleared CT Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · PSZ
Quidel Corporation
Microbiology · 90d
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 CT 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