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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 K854447
Device Name IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
Applicant
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Applicant Contact KRISTA UNDERWOOD
Correspondent
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Correspondent Contact KRISTA UNDERWOOD
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received11/05/1985
Decision Date 01/03/1986
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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