URICAR

Acid, Uric, Uricase (colorimetric)

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Uricar.

Pre-market Notification Details

Device IDK812700
510k NumberK812700
Device Name:URICAR
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-23
Decision Date1981-11-05

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