URIC ACID

Acid, Uric, Uricase (u.v.)

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Uric Acid.

Pre-market Notification Details

Device IDK981189
510k NumberK981189
Device Name:URIC ACID
ClassificationAcid, Uric, Uricase (u.v.)
Applicant ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving,  TX  75038
ContactMark Littlefield
CorrespondentMark Littlefield
ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving,  TX  75038
Product CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-02
Decision Date1998-05-07
Summary:summary

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