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
121–144 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 09, 2025
Access anti-HAV
K243846 · LOL
Beckman Coulter, Inc.
Microbiology · 267d
Cleared Sep 05, 2025
GenaCheck COVID-19 Rapid Self-Test
K251753 · QYT
Genabio Diagnostics, Inc.
Microbiology · 88d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Thermo Fisher Scientific
Microbiology · 191d
Cleared Aug 28, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252014 · JWY
Thermo Fisher Scientific
Microbiology · 62d
Cleared Aug 27, 2025
QIAstat-Dx Respiratory Panel Plus
K250080 · QOF
QIAGEN GmbH
Microbiology · 226d
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Access Bio, Inc.
Microbiology · 87d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
WELLlife Flu A&B Home Test
K251563 · SCA
Wondfo USA Co., Ltd.
Microbiology · 90d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...
K250036 · LTT
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Aug 14, 2025
FilmArray GI Control Panel M238
K251526 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Aug 14, 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
K243544 · QOF
Biofire Diagnostics, LLC
Microbiology · 272d
Cleared Aug 13, 2025
MBT Compass HT CA Software
K251495 · QBN
Bruker Daltonics GmbH & Co. KG
Microbiology · 90d
Cleared Aug 12, 2025
Sulopenem SPM 2 µg
K251879 · JTN
Liofilchem
Microbiology · 55d
Cleared Aug 08, 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · LON
Becton, Dickinson and Company
Microbiology · 66d
Cleared Aug 01, 2025
MycoMEIA Aspergillus Assay
K243496 · NOM
Pearl Diagnostics, Inc.
Microbiology · 262d
Cleared Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · QOF
Roche Molecular Systems, Inc.
Microbiology · 266d
Cleared Jul 28, 2025
Alinity m EBV (09N43-095)
K243489 · QLX
Abbott Molecular, Inc.
Microbiology · 258d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...
K250084 · LTT
Beckman Coulter, Inc.
Microbiology · 186d
Cleared Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...
K243274 · OZE
Centers For Disease Control and...
Microbiology · 268d
Cleared Jul 03, 2025
Innovita Flu A/B Antigen Rapid Test
K250398 · PSZ
Innovita (Tangshan) Biological...
Microbiology · 141d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d