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FDA 510(k)

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

K-Number: K162538 · 2016-11-17

ApplicantSiemens Healthcare Diagnostics
Decision Date2016-11-17
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is a medical device manufactured by Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-11-17 under approval number K162538. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Siemens Healthcare Diagnostics. The 510(k) number is K162538.

When was ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator approved by the FDA?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator received FDA 510(k) clearance on 2016-11-17, under approval number K162538.

What company makes ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is manufactured by Siemens Healthcare Diagnostics.

What is the FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

The FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is JIT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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