GEMENI AST-LTS REAGENTS

Nadh Oxidation/nad Reduction, Ast/sgot

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemeni Ast-lts Reagents.

Pre-market Notification Details

Device IDK851267
510k NumberK851267
Device Name:GEMENI AST-LTS REAGENTS
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLa Brec
CorrespondentLa Brec
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-29
Decision Date1985-04-29

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