AS LATEX PLUS

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 As Latex Plus.

Pre-market Notification Details

Device IDK842256
510k NumberK842256
Device Name:AS LATEX PLUS
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant BIOKIT USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-07
Decision Date1984-06-19

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