BIOTROL AST/TGO MONOREACTIF

Nadh Oxidation/nad Reduction, Ast/sgot

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Ast/tgo Monoreactif.

Pre-market Notification Details

Device IDK872829
510k NumberK872829
Device Name:BIOTROL AST/TGO MONOREACTIF
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-17
Decision Date1987-08-13

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