QUANTEX RF PLUS (LATEX, BUFFER STANDARD, 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 Quantex Rf Plus (latex, Buffer Standard, Control).

Pre-market Notification Details

Device IDK896271
510k NumberK896271
Device Name:QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
ClassificationSystem, Test, Rheumatoid Factor
Applicant BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona,  ES
ContactOdriozola
CorrespondentOdriozola
BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona,  ES
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-30
Decision Date1989-11-08

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