510(k) K251538— Status COVID-19/Flu A&B

Substantially Equivalent

Princeton BioMeditech Corp.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code SCA
Advisory panel: Microbiology
Date received: 2025-05-19
Decision date: 2025-11-14
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Monmouth Junction, NJ, US

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