AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325

Enzymatic Esterase--oxidase, Cholesterol

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Cholesterol Reagents, Prod. # 7325.

Pre-market Notification Details

Device IDK891922
510k NumberK891922
Device Name:AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
ClassificationEnzymatic Esterase--oxidase, Cholesterol
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 CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-27
Decision Date1989-06-16

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