SYSTEMATE URICACID TEST, TECHNICON RA 1000

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 Systemate Uricacid Test, Technicon Ra 1000.

Pre-market Notification Details

Device IDK923765
510k NumberK923765
Device Name:SYSTEMATE URICACID TEST, TECHNICON RA 1000
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 Received1992-07-28
Decision Date1992-09-22

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