FDA 510(k)

Creatine Kinase

Número K: K160570 · 2016-05-25

RequerenteRoche Diagnostics Operations (Rdo)

Data da decisão2016-05-25

Código do produtoJHS

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Creatine Kinase is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K160570. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Creatine Kinase?

Creatine Kinase is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160570.

When did Creatine Kinase receive FDA 510(k) clearance?

Creatine Kinase received FDA 510(k) clearance on 2016-05-25, under 510(k) number K160570.

Who is the listed applicant for Creatine Kinase?

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

What is the FDA product code for Creatine Kinase?

The FDA product code for Creatine Kinase is JHS.

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