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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 K910797
Device Name STREPTEX ACID EXTRACTION KIT
Applicant
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Applicant Contact KAFADER II
Correspondent
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Correspondent Contact KAFADER II
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received02/26/1991
Decision Date 03/29/1991
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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