ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator— 510(k) K162538

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K162538 for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator, Substantially Equivalent on 2016-11-17. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.