AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Triglycerides Reagents (products 7730).

Pre-market Notification Details

Device IDK894310
510k NumberK894310
Device Name:AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactC. K Owens
CorrespondentC. K Owens
AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-09-28

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