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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 K860923
Device Name EZ DETECT, 5 MINUTE STREP-A COLOR TEST
Applicant
Self Care Systems, Inc.
1527 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact CHANDRAVADAN PATEL
Correspondent
Self Care Systems, Inc.
1527 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact CHANDRAVADAN PATEL
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received03/11/1986
Decision Date 05/16/1986
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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