ENZYMATIC URIC ACID REAGENT

Acid, Uric, Uricase (colorimetric)

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Uric Acid Reagent.

Pre-market Notification Details

Device IDK860732
510k NumberK860732
Device Name:ENZYMATIC URIC ACID REAGENT
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactW. C Riddle
CorrespondentW. C Riddle
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-26
Decision Date1986-04-16

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