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
793–816 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 10, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...
K162642 · PSZ
Alere Scarborough, Inc.
Microbiology · 200d
Cleared Mar 31, 2017
Great Basin Bordetella Direct Test
K170284 · OZZ
Great Basin Scientific, Inc.
Microbiology · 60d
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · MDB
bioMerieux, Inc.
Microbiology · 270d
Cleared Mar 21, 2017
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4-...
K163637 · LON
Becton, Dickinson Company
Microbiology · 88d
Cleared Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · LTT
Beckman Coulter, Inc.
Microbiology · 172d
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569 · LFZ
Roche Diagnostics
Microbiology · 88d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 14, 2017
FilmArray Warrior Control Panel M290
K163522 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 89d
Cleared Mar 14, 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
K163517 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Mar 06, 2017
Greiner Vacuette Urine Count and Culture, Mannitol tube
K163436 · JSM
Greiner Bio-One Na, Inc.
Microbiology · 89d
Cleared Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827 · PRI
bioMerieux, Inc.
Microbiology · 139d
Not Cleared Feb 23, 2017
Accelerate Pheno system, Accelerate Phenotest BC Kit
DEN160032 · PRH
Accelerate Diagnotics
Microbiology · 227d
Cleared Feb 22, 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
K163298 · JWY
Liofilchem S. R. L.
Microbiology · 92d
Cleared Feb 22, 2017
Sofia RSV FIA on Sofia 2 analyzer
K162911 · GQG
Quidel Corporation
Microbiology · 128d
Cleared Feb 21, 2017
TRU Legionella
K163273 · MJH
Meridian Bioscience, Inc.
Microbiology · 92d
Cleared Feb 17, 2017
SeptiCyte LAB
K163260 · PRE
Immunexpress, Inc.
Microbiology · 88d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Feb 14, 2017
Simplexa C. difficile Direct
K163085 · OZN
Focus Diagnostics, Inc.:Dba Diasorin...
Microbiology · 103d
Not Cleared Feb 14, 2017
FilmArray NGDS Warrior Panel
DEN160048 · PRD
Biofire Defense, LLC
Microbiology · 120d
Cleared Feb 13, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx...
K162456 · OCC
Cepheid
Microbiology · 164d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · LON
bioMerieux, Inc.
Microbiology · 257d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184 · LSL
Roche Molecular Systems, Inc.
Microbiology · 87d
Cleared Feb 09, 2017
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K162331 · OCC
Cepheid
Microbiology · 174d