AST/SGOT

Nadh Oxidation/nad Reduction, Ast/sgot

DERMA MEDIA LAB., INC.

The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Ast/sgot.

Pre-market Notification Details

Device IDK965126
510k NumberK965126
Device Name:AST/SGOT
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs,  CA  90670
ContactCharles C Allain, Ph.d.
CorrespondentCharles C Allain, Ph.d.
DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs,  CA  90670
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-23
Decision Date1997-01-17

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