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
937–960 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 CT 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
Cleared Aug 28, 2015
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K150962 · OQO
Focus Diagnostics
Microbiology · 140d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with...
K150556 · JWY
Thermo Fisher Scientific
Microbiology · 177d
Cleared Aug 25, 2015
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · PCH
Becton, Dickinson and Company
Microbiology · 246d
Cleared Aug 12, 2015
Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935 · LYR
Alere San Diego, Incorporated
Microbiology · 29d
Cleared Jul 28, 2015
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control...
K151464 · OCC
Alere Scarborough, Inc.
Microbiology · 57d
Cleared Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K150236 · JWY
Thermo Fisher Scientific
Microbiology · 175d
Cleared Jul 17, 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External...
K151046 · PGI
Meridian Bioscience, Inc.
Microbiology · 88d
Cleared Jul 16, 2015
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
K151690 · OOI
Alere Scarborough, Inc.
Microbiology · 23d
Cleared Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,...
K141133 · LYR
BIOMERIEUX
Microbiology · 434d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 174d
Cleared Jul 02, 2015
Theranos Herpes Simplex Virus-1 IgG Assay
K143236 · MXJ
Theranos, Inc.
Microbiology · 232d
Cleared Jun 23, 2015
Solana GAS Assay, Solana instrument
K150868 · PGX
Quidel Corporation
Microbiology · 83d
Cleared Jun 10, 2015
BD Veritor (TM) System for the Rapid Detection of Flu A+B
K151291 · PSZ
Becton, Dickinson and Company
Microbiology · 26d
Cleared Jun 08, 2015
BD Veritor™ System Flu A+B Assay
K151301 · PSZ
Becton, Dickinson and Company
Microbiology · 24d