ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Enzymatic Triglycerides Gpo-trinder Method.

Pre-market Notification Details

Device IDK871301
510k NumberK871301
Device Name:ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
ContactLuann Ochs
CorrespondentLuann Ochs
AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-01
Decision Date1987-04-22

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