RHEUMAGEN RF T-CONTROL

System, Test, Rheumatoid Factor

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Rf T-control.

Pre-market Notification Details

Device IDK904310
510k NumberK904310
Device Name:RHEUMAGEN RF T-CONTROL
ClassificationSystem, Test, Rheumatoid Factor
Applicant BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
ContactOdriozola
CorrespondentOdriozola
BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-19
Decision Date1991-05-31

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