URIC ACID TEST ITEM NUMBER 65422

Acid, Uric, Uricase (u.v.)

EM DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Uric Acid Test Item Number 65422.

Pre-market Notification Details

Device IDK932162
510k NumberK932162
Device Name:URIC ACID TEST ITEM NUMBER 65422
ClassificationAcid, Uric, Uricase (u.v.)
Applicant EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown,  NJ  08027
ContactCarol Faulkner
CorrespondentCarol Faulkner
EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown,  NJ  08027
Product CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-04
Decision Date1993-09-27

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