ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator

Calibrator, Secondary

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Insulin (iri) Master Curve Material (mcm), Advia Centaur (iri) Calibrator.

Pre-market Notification Details

Device IDK162538
510k NumberK162538
Device Name:ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
ClassificationCalibrator, Secondary
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET E. Walpole,  MA  02032
ContactSusan Ferrin
CorrespondentSusan Ferrin
SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET E. Walpole,  MA  02032
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-12
Decision Date2016-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414600451 K162538 000
00630414600482 K162538 000

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