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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K182157
Device Name BioSign Flu A+B
Applicant
Princeton BioMeditech Corp.
4242 Us Highway 1
Monmouth Junction,  NJ  08852
Applicant Contact Kyung-ah Kim
Correspondent
Princeton BioMeditech Corp.
4242 Us Highway 1
Monmouth Junction,  NJ  08852
Correspondent Contact Kyung-ah Kim
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/09/2018
Decision Date 09/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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