UA(URICASE) REAGENT

Acid, Uric, Uricase (colorimetric)

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Ua(uricase) Reagent.

Pre-market Notification Details

Device IDK852004
510k NumberK852004
Device Name:UA(URICASE) REAGENT
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactYosip F Warda
CorrespondentYosip F Warda
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-05-29

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