FDA 510(k)

ADVIA Centaur Insulina (IRI) Material de Curva Principal (MCM), ADVIA Centaur (IRI) Calibrador

Número K: K162538 · 2016-11-17

RequerenteSiemens Healthcare Diagnostics

Data da decisão2016-11-17

Código do produtoJIT

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162538.

When did ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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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