AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI

Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

AMRESCO, INC.

The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Subst Concen, Pro #2432,buf,nad,2455,tri.

Pre-market Notification Details

Device IDK852948
510k NumberK852948
Device Name:AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
ClassificationNad Reduction/nadh Oxidation, Lactate Dehydrogenase
Applicant AMRESCO, INC. P.O. BOX 21009 South Euclid,  OH  44121
ContactTimothy J Belcastro
CorrespondentTimothy J Belcastro
AMRESCO, INC. P.O. BOX 21009 South Euclid,  OH  44121
Product CodeCFJ  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-11
Decision Date1985-08-07

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