FDA 510(k)

Tina-quant C-Reactive Protein IV

Número K: K192072 · 2020-02-21

RequerenteRoche Diagnostics Operations (Rdo)

Data da decisão2020-02-21

Código do produtoDCN

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tina-quant C-Reactive Protein IV 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 2020-02-21 under 510(k) number K192072. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tina-quant C-Reactive Protein IV?

Tina-quant C-Reactive Protein IV is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K192072.

When did Tina-quant C-Reactive Protein IV receive FDA 510(k) clearance?

Tina-quant C-Reactive Protein IV received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192072.

Who is the listed applicant for Tina-quant C-Reactive Protein IV?

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 Tina-quant C-Reactive Protein IV?

The FDA product code for Tina-quant C-Reactive Protein IV is DCN.

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Fonte oficial

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