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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 K854991
Device Name REUMAGEN ASL
Applicant
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact ANGELES RODRIGUEZ
Correspondent
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact ANGELES RODRIGUEZ
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received12/12/1985
Decision Date 04/18/1986
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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