BAYER ADVIA IMS SYSTEM

Diazo Colorimetry, Bilirubin

BAYER CORP.

The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System.

Pre-market Notification Details

Device IDK993867
510k NumberK993867
Device Name:BAYER ADVIA IMS SYSTEM
ClassificationDiazo Colorimetry, Bilirubin
Applicant BAYER CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactGabriel J Muraca
CorrespondentGabriel J Muraca
BAYER CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeCIG  
Subsequent Product CodeJGJ
Subsequent Product CodeKLS
Subsequent Product CodeKNK
Subsequent Product CodeLCD
Subsequent Product CodeLCP
Subsequent Product CodeLDO
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-15
Decision Date2000-04-10
Summary:summary

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