FAST URIC ACID

Acid, Uric, Uricase (colorimetric)

SCLAVO, INC.

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

Pre-market Notification Details

Device IDK870632
510k NumberK870632
Device Name:FAST URIC ACID
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-13
Decision Date1987-03-13

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