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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K896109
Device Name IMMUNOCARD STREP A TEST
Applicant
Disease Detection International, Inc.
17935 Sky Park Circle, Suite
D
Irvine,  CA  92714
Applicant Contact JULIE WHITESIDE
Correspondent
Disease Detection International, Inc.
17935 Sky Park Circle, Suite
D
Irvine,  CA  92714
Correspondent Contact JULIE WHITESIDE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received10/23/1989
Decision Date 11/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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