BIOTROL ALT/TGP MONOREACTIF

Nadh Oxidation/nad Reduction, Alt/sgpt

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK872830
510k NumberK872830
Device Name:BIOTROL ALT/TGP MONOREACTIF
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
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 CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-17
Decision Date1987-08-13

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