URIC ACID (URICASE) METHOD-II

Acid, Uric, Uricase (oxygen Rate)

CATACHEM, INC.

The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Uric Acid (uricase) Method-ii.

Pre-market Notification Details

Device IDK863287
510k NumberK863287
Device Name:URIC ACID (URICASE) METHOD-II
ClassificationAcid, Uric, Uricase (oxygen Rate)
Applicant CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
ContactLuis P Leon
CorrespondentLuis P Leon
CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
Product CodeJHC  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-09-29

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