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
817–840 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 01, 2017
Remel Spectra ESBL
K162620 · JSO
Remel, Inc.
Microbiology · 223d
Cleared Apr 27, 2017
RAPIDEC CARBA NP
K162385 · PTJ
Biomerieux S.A.
Microbiology · 245d
Cleared Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator...
K162297 · PTF
Diazyme Laboratories
Microbiology · 245d
Cleared Apr 14, 2017
Sofia Influenza A+B FIA on Sofia 2
K162438 · PSZ
Quidel Corporation
Microbiology · 226d
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 CT 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