BIOTROL AMYLASE CNPG3

Saccharogenic, Amylase

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Amylase Cnpg3.

Pre-market Notification Details

Device IDK931141
510k NumberK931141
Device Name:BIOTROL AMYLASE CNPG3
ClassificationSaccharogenic, Amylase
Applicant BIOTROL, USA, INC. 115 SUMMIT DR. Exton,  PA  19341
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 115 SUMMIT DR. Exton,  PA  19341
Product CodeCIJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-05
Decision Date1993-05-26

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