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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K971349
Device Name BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Correspondent Contact JEMO KANG
Regulation Number866.3740
Classification Product Code
GTY  
Date Received04/10/1997
Decision Date 07/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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