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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K904311
Device Name RHEUMAGEN ASO T-CONTROL
Applicant
Biokit USA, Inc.
Llissa D'Amunt
08186 Barcelona, Spain
Barcelona,  ES
Applicant Contact ODRIOZOLA
Correspondent
Biokit USA, Inc.
Llissa D'Amunt
08186 Barcelona, Spain
Barcelona,  ES
Correspondent Contact ODRIOZOLA
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received09/19/1990
Decision Date 01/25/1991
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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