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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K904312
Device Name RHEUMAGEN CRP T-CONTROL
Applicant
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact ODRIOZOLA
Correspondent
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact ODRIOZOLA
Regulation Number866.5270
Classification Product Code
DCK  
Date Received09/19/1990
Decision Date 10/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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