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
769–792 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 01, 2017
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT...
K170652 · PRI
Fisher Diagnostics
Microbiology · 90d
Cleared May 31, 2017
B R A H M S PCT sensitive KRYPTOR
K171338 · PRI
Brahms GmbH
Microbiology · 23d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · JWY
bioMerieux, Inc.
Microbiology · 86d
Cleared May 30, 2017
FilmArray Respiratory Panel 2 (RP2)
K170604 · OCC
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared May 25, 2017
revogene
K170558 · OOI
Genepoc, Inc.
Microbiology · 90d
Cleared May 25, 2017
GenePOC GBS LB
K170557 · NJR
Genepoc, Inc.
Microbiology · 90d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · PQZ
Hardy Diagnostics
Microbiology · 83d
Cleared May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...
K170509 · PUQ
Bio-Rad Laboratories
Microbiology · 87d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · PQZ
Hardy Diagnostics
Microbiology · 89d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · OZN
Quidel Corporation
Microbiology · 83d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...
K170413 · LIP
Bio-Rad Laboratories
Microbiology · 90d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · PCH
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 02, 2017
ARIES Bordetella Assay
K163626 · OZZ
Luminex Corporation
Microbiology · 131d
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