ASPARTATE AMINOTRANFERASE (AST)

Nadh Oxidation/nad Reduction, Ast/sgot

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Aspartate Aminotranferase (ast).

Pre-market Notification Details

Device IDK896000
510k NumberK896000
Device Name:ASPARTATE AMINOTRANFERASE (AST)
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
ContactJennifer Line
CorrespondentJennifer Line
AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-13
Decision Date1990-01-11

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