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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Respiratory Virus Antigen Detection Test
510(k) Number K251538
Device Name Status™ COVID-19/Flu A&B
Applicant
Princeton BioMeditech Corp.
4242 U.S. Hwy. 1
Monmouth Junction,  NJ  08852
Applicant Contact Young-A Kim
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Hwy. 1
Monmouth Junction,  NJ  08852
Correspondent Contact Young-A Kim
Classification Product Code
SCA  
Date Received05/19/2025
Decision Date 11/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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