ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

Bromcresol Green Dye-binding, Albumin

BAYER CORP.

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

Pre-market Notification Details

Device IDK992399
510k NumberK992399
Device Name:ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
ClassificationBromcresol Green Dye-binding, Albumin
Applicant BAYER CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactGabriel J Muracaa Jr
CorrespondentGabriel J Muracaa Jr
BAYER CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeCIX  
Subsequent Product CodeCEM
Subsequent Product CodeCEO
Subsequent Product CodeCGZ
Subsequent Product CodeCHH
Subsequent Product CodeCHS
Subsequent Product CodeCIG
Subsequent Product CodeJGS
Subsequent Product CodeKXT
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-19
Decision Date1999-09-15
Summary:summary

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