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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K910541
Device Name BIOKIT RPR
Applicant
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact IGNACIO ODRIOZOLA
Correspondent
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact IGNACIO ODRIOZOLA
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received02/04/1991
Decision Date 10/18/1991
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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