URIC ACID KIT, CODES 4825400 AND 4825050

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 Uric Acid Kit, Codes 4825400 And 4825050.

Pre-market Notification Details

Device IDK890319
510k NumberK890319
Device Name:URIC ACID KIT, CODES 4825400 AND 4825050
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactDianne Eich
CorrespondentDianne Eich
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 Received1989-01-23
Decision Date1989-04-12

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