CARESIDE URIC ACID

Acid, Uric, Uricase (colorimetric)

CARESIDE, INC.

The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Uric Acid.

Pre-market Notification Details

Device IDK981604
510k NumberK981604
Device Name:CARESIDE URIC ACID
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-28
Decision Date1998-06-25
Summary:summary

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