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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K896271
Device Name QUANTEX RF PLUS (LATEX, BUFFER STANDARD, 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 Number866.5775
Classification Product Code
DHR  
Date Received10/30/1989
Decision Date 11/08/1989
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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