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ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator — Siemens Healthcare Diagnostics (510(k) K

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator — Siemens Healthcare Diagnostics (510(k) K is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator; Applicant:

Device nameADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
ApplicantSiemens Healthcare Diagnostics
Clearance track510(k)
Submission numberK162538
DecisionSubstantially Equivalent
Decision date2016-11-17
Date received2016-09-12
Product codeJIT
Device class2
Medical specialtyClinical Chemistry
Applicant locationMA, US
SourceopenFDA device

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