ENZYMATIC TRIGLYCERIDES GPO-GRINDER 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-grinder Method.

Pre-market Notification Details

Device IDK854366
510k NumberK854366
Device Name:ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
ContactLinda M Chinn
CorrespondentLinda M Chinn
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 Received1985-10-29
Decision Date1985-11-25

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