ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

Calibrator, Multi-analyte Mixture

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Drug Calibrator I Model 10376770.

Pre-market Notification Details

Device IDK093732
510k NumberK093732
Device Name:ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
ClassificationCalibrator, Multi-analyte Mixture
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
ContactKira Gordon
CorrespondentKira Gordon
SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-04
Decision Date2010-03-22
Summary:summary

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