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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 K860576
Device Name MUREX SUDS GROUP A STREP
Applicant
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Applicant Contact DAVID L MARSHALL
Correspondent
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Correspondent Contact DAVID L MARSHALL
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received02/18/1986
Decision Date 04/04/1986
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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