BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

Calibrator, Multi-analyte Mixture

BAYER HEALTHCARE, LLC

The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Advia 1650 Special Chemistry Calibrator.

Pre-market Notification Details

Device IDK030804
510k NumberK030804
Device Name:BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
ClassificationCalibrator, Multi-analyte Mixture
Applicant BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactAndres Holle
CorrespondentAndres Holle
BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-13
Decision Date2003-04-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.