FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
913–936 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
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
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617 · OQO
Roche Molecular Systems, Inc.
Microbiology · 83d
Cleared May 29, 2015
Para-Fix C&S Medium
K150887 · JSM
Medical Chemical Corporation
Microbiology · 57d
Cleared May 20, 2015
cobas Cdiff Test
K142422 · OZN
Roche Molecular Systems, Inc.
Microbiology · 265d
Cleared May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
K142038 · LSR
Euroimmun US
Microbiology · 280d