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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K870409
Device Name CHROMAGEN TEST FOR GROUP A STREP
Applicant
Diversified Diagnostic Industries
1640 School St.
Suite 101
Moraga,  CA  94556
Applicant Contact MARY J HIRD
Correspondent
Diversified Diagnostic Industries
1640 School St.
Suite 101
Moraga,  CA  94556
Correspondent Contact MARY J HIRD
Regulation Number866.2660
Classification Product Code
JTO  
Date Received02/03/1987
Decision Date 04/15/1987
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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