AMRESCO URIC ACID REAGENTS #7628

Acid, Uric, Uricase (colorimetric)

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Uric Acid Reagents #7628.

Pre-market Notification Details

Device IDK892395
510k NumberK892395
Device Name:AMRESCO URIC ACID REAGENTS #7628
ClassificationAcid, Uric, Uricase (colorimetric)
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 CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-07
Decision Date1989-05-24

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