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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 K962296
Device Name STREPTOLEX-STAT
Applicant
Unipath , Ltd.
15 Oak St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Unipath , Ltd.
15 Oak St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received06/12/1996
Decision Date 12/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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