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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 K133474
Device Name BIOSIGN FLU A + B, STATUS FLU A & B
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION,  NJ  08852 -1905
Applicant Contact KYUNG-AH KIM
Correspondent
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION,  NJ  08852 -1905
Correspondent Contact KYUNG-AH KIM
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received11/12/2013
Decision Date 12/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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