SGPT/ALT REAGENT SYSTEM

Nadh Oxidation/nad Reduction, Alt/sgpt

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Sgpt/alt Reagent System.

Pre-market Notification Details

Device IDK780791
510k NumberK780791
Device Name:SGPT/ALT REAGENT SYSTEM
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-15
Decision Date1978-06-13

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