RHEUMAGEN ASO T-CONTROL

Antistreptolysin - Titer/streptolysin O Reagent

BIOKIT USA, INC.

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

Pre-market Notification Details

Device IDK904311
510k NumberK904311
Device Name:RHEUMAGEN ASO T-CONTROL
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
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 CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-19
Decision Date1991-01-25

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