K162538

Substantially Equivalent

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

Applicant: Siemens Healthcare Diagnostics
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2016-09-12
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: East Walpole, MA, US

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