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
481–504 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 352d
Cleared Nov 20, 2020
FilmArray Global Fever Panel External Control Kit
K202382 · PMN
Biofire Defense, LLC
Microbiology · 92d
Not Cleared Nov 20, 2020
FilmArray Global Fever Panel
DEN200043 · QMV
Biofire Defense, LLC
Microbiology · 147d
Cleared Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64...
K202343 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Nov 09, 2020
Accula Strep A Test
K201269 · PGX
Mesa Biotech, Inc.
Microbiology · 181d
Cleared Oct 21, 2020
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI...
K201438 · GMQ
Arlington Scientific, Inc. (Asi)
Microbiology · 142d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · LON
bioMerieux, Inc.
Microbiology · 306d
Cleared Sep 17, 2020
eNAT molecular collection and preservation medium
K201849 · QBD
Copan Italia Spa
Microbiology · 73d
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665 · PRH
Accelerate Diagnostics, Inc.
Microbiology · 356d
Cleared Sep 02, 2020
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
K202215 · QMI
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Aug 30, 2020
LabPro Data Management System
K201405 · LON
Beckman Coulter, Inc.
Microbiology · 94d
Cleared Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control...
K201505 · OCC
Diasorin Molecular, LLC
Microbiology · 78d
Not Cleared Jul 30, 2020
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
DEN200015 · QLX
Roche Molecular Systems, Inc.
Microbiology · 150d
Cleared Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32...
K201423 · LTT
Beckman Coulter, Inc.
Microbiology · 31d
Cleared Jun 03, 2020
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
K200506 · QFO
Chembio Diagnostic Systems
Microbiology · 93d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · QEP
Hologic, Inc.
Microbiology · 46d
Not Cleared May 11, 2020
NP Screen
DEN190031 · OJY
Advance Sentry Corporation
Microbiology · 322d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · JWY
Biom?rieux SA
Microbiology · 66d
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · QEP
Binx Health, Inc.
Microbiology · 56d
Cleared Apr 06, 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · JWY
Liofilchem S. R. 1.
Microbiology · 60d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K200025 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023 · LSR
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 03, 2020
Osom Ultra Plus Flu A&B Test Kit
K192719 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 190d