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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 K934383
Device Name PROLEX (STREPTOCCAL GROUPING LATEX KIT)
Applicant
Pro-Lab, Inc.
20 Mural St., #4
Richmond Hill, Ontario,  CA L4B 1K3
Applicant Contact ROBERT RAE
Correspondent
Pro-Lab, Inc.
20 Mural St., #4
Richmond Hill, Ontario,  CA L4B 1K3
Correspondent Contact ROBERT RAE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/09/1993
Decision Date 01/27/1995
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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