AMRESCO CREATININE REAGENT #4316100

Alkaline Picrate, Colorimetry, Creatinine

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Creatinine Reagent #4316100.

Pre-market Notification Details

Device IDK896686
510k NumberK896686
Device Name:AMRESCO CREATININE REAGENT #4316100
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-28
Decision Date1990-02-08

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