DASH® SARS-CoV-2 & Flu A/B Test— 510(k) K241652

Substantially Equivalent

Nuclein, LLC

FDA 510(k) clearance K241652 for DASH® SARS-CoV-2 & Flu A/B Test, Substantially Equivalent on 2024-12-20. Applicant: Nuclein, LLC.

Clearance details

Applicant
Nuclein, LLC
Product code
Code QOF
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
Austin, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.