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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 K862133
Device Name HYGEIA RAPID STREP A TEST
Applicant
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Applicant Contact BERKE, PH.D.
Correspondent
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Correspondent Contact BERKE, PH.D.
Regulation Number866.3740
Classification Product Code
GTY  
Date Received06/04/1986
Decision Date 06/25/1986
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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