BIOTROL CHOLESTEROL ENZYMATIQUE COLOR

Enzymatic Esterase--oxidase, Cholesterol

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Cholesterol Enzymatique Color.

Pre-market Notification Details

Device IDK872930
510k NumberK872930
Device Name:BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
ClassificationEnzymatic Esterase--oxidase, Cholesterol
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 CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-27
Decision Date1987-08-21

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