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
505–528 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 29, 2021
cobas BKV
K203220 · QLX
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · QEP
Roche Molecular Systems, Inc.
Microbiology · 153d
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · QNJ
Bruker Daltonik GmbH
Microbiology · 384d
Cleared Dec 14, 2020
DNA/RNA Shield Collection Tube
K202641 · QBD
Zymo Research
Microbiology · 94d
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 CT Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · QEP
Binx Health, Inc.
Microbiology · 56d