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
529–552 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Apr 02, 2020
FilmArray BCID2 Control Panel M416
K200010 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 91d
Cleared Mar 23, 2020
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris)...
K200436 · QEP
Hologic, Inc.
Microbiology · 28d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004...
K193536 · LTT
Beckman Coulter, Inc.
Microbiology · 89d
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · PEN
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
K193572 · LON
bioMerieux, Inc.
Microbiology · 81d
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817 · LYR
Meridian Bioscience, Inc.
Microbiology · 164d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 10, 2020
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K200370 · OZE
Centers For Disease Control and...
Microbiology · 25d
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815 · PRI
Roche Diagnostics
Microbiology · 160d
Cleared Mar 05, 2020
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · MJH
Ssi Diagnostica A/S
Microbiology · 307d
Cleared Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx)...
K193358 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Mar 02, 2020
LIAISON Anti-HAV Assay
K193532 · LOL
DiaSorin, Inc.
Microbiology · 73d
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · PMT
Ortho-Clinical Diagnostics
Microbiology · 26d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · PSZ
Access Bio, Inc.
Microbiology · 256d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas...
K200065 · OCC
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Jan 29, 2020
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
K193051 · LSR
DiaSorin, Inc.
Microbiology · 89d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d