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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Control For Nontreponemal Tests
510(k) Number K843741
Device Name RPR TEST REDITEST
Applicant
Biokit USA, Inc.
Corcega 603-605
08025
Barcelona, Spain, 
Applicant Contact ANGELES RODRIQUEZ
Correspondent
Biokit USA, Inc.
Corcega 603-605
08025
Barcelona, Spain, 
Correspondent Contact ANGELES RODRIQUEZ
Regulation Number866.3820
Classification Product Code
GMP  
Date Received09/25/1984
Decision Date 10/25/1984
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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