AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791

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 Reagents Product #7790, 7791.

Pre-market Notification Details

Device IDK900666
510k NumberK900666
Device Name:AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactOwens
CorrespondentOwens
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 Received1990-02-13
Decision Date1990-04-19

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