BIOTROL LACTATE DEHYDROGENASE (L-P)

Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Lactate Dehydrogenase (l-p).

Pre-market Notification Details

Device IDK905683
510k NumberK905683
Device Name:BIOTROL LACTATE DEHYDROGENASE (L-P)
ClassificationNad Reduction/nadh Oxidation, Lactate Dehydrogenase
Applicant BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
Product CodeCFJ  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-19
Decision Date1991-03-11

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