URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Acid, Uric, Uricase (colorimetric)

BAYER DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Uric Acid Assay For The Advia Integrated Modular System.

Pre-market Notification Details

Device IDK022096
510k NumberK022096
Device Name:URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactKenneth T Edds
CorrespondentKenneth T Edds
BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-27
Decision Date2003-03-18
Summary:summary

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