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
865–888 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
K161495 · OOI
Luminex Corporation
Microbiology · 29d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · POC
Cepheid
Microbiology · 89d
Cleared Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911 · PMT
bioMerieux, Inc.
Microbiology · 88d
Cleared Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · JWY
Liofilchem S. R. L.
Microbiology · 190d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...
K153730 · LIP
Abbott Laboratories
Microbiology · 170d
Cleared Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma...
K160829 · OZX
Meridian Bioscience, Inc.
Microbiology · 80d
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · PMT
Roche Diagnostics
Microbiology · 89d
Cleared May 13, 2016
SeraQuest HSV Type 2 Specific IgG
K152353 · MYF
Quest International, Inc.
Microbiology · 267d
Cleared May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...
K152679 · PMN
Bio-Rad Laboratories
Microbiology · 235d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · LON
bioMerieux, Inc.
Microbiology · 263d
Cleared Apr 12, 2016
ARIES System
K160517 · OOI
Luminex Corporation
Microbiology · 48d
Cleared Apr 01, 2016
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
K160459 · PCH
Biofire Diagnostics, LLC
Microbiology · 42d
Cleared Mar 31, 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · JWY
Liofilchem S. R. L.
Microbiology · 99d
Not Cleared Mar 28, 2016
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...
DEN150058 · PMN
Bio-Rad Laboratories
Microbiology · 103d
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470 · PAM
Great Basin Scientific, Inc.
Microbiology · 207d
Cleared Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
K151923 · NGZ
bioMerieux, Inc.
Microbiology · 256d
Cleared Mar 22, 2016
Great Basin Shiga Toxin Direct Test
K152955 · PCH
Great Basin Scientific, Inc.
Microbiology · 167d
Cleared Mar 17, 2016
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
K160462 · PLO
Biofire Diagnostics, LLC
Microbiology · 27d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · PEN
Biofire Diagnostics, LLC
Microbiology · 25d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661 · LYR
Meridian Bioscience, Inc.
Microbiology · 84d
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