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FDA PMA

Assay, enzyme linked immunosorbent, hepatitis c virus

Número do PMA: P090009 · 2019-04-24

RequerenteRoche Diagnostics Corp.
Data da decisão2019-04-24
Número PMAP090009
Código do produtoMZO
Classe do DispositivoClasse 2
Especialidade MédicaM
Número da Regulamentação21 CFR 8
Comité consultivoMI

Resumo do dispositivo

Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2019-04-24. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

Perguntas frequentes

What is the Assay, enzyme linked immunosorbent, hepatitis c virus?

Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2019-04-24. The listed applicant is Roche Diagnostics Corp..

When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?

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

What is the FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus?

The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.

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