ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY 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 Assays For The Bayer Advia 1650 Chemistry System.

Pre-market Notification Details

Device IDK991576
510k NumberK991576
Device Name:ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
ClassificationBromcresol Green Dye-binding, Albumin
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 CodeCIX  
Subsequent Product CodeCDQ
Subsequent Product CodeCEO
Subsequent Product CodeCFO
Subsequent Product CodeCFR
Subsequent Product CodeCGA
Subsequent Product CodeCGS
Subsequent Product CodeCGX
Subsequent Product CodeCIC
Subsequent Product CodeCIG
Subsequent Product CodeCIT
Subsequent Product CodeCJK
Subsequent Product CodeJFY
Subsequent Product CodeJIY
Subsequent Product CodeKHM
Subsequent Product CodeKNK
Subsequent Product CodeLBS
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-06
Decision Date1999-06-30
Summary:summary

NIH GUDID Devices

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