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
865–888 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
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 Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · PSZ
Quidel Corporation
Microbiology · 90d