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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 K083746
Device Name BIOSIGN 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 Received12/17/2008
Decision Date 11/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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