FDA 510(k)

VITROS Chemistry Products PHBR Slides

Número K: K210858 · 2021-08-13

RequerenteOrtho-Clinical Diagnostics, Inc.

Data da decisão2021-08-13

Código do produtoDLZ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITROS Chemistry Products PHBR Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K210858. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITROS Chemistry Products PHBR Slides?

VITROS Chemistry Products PHBR Slides is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K210858.

When did VITROS Chemistry Products PHBR Slides receive FDA 510(k) clearance?

VITROS Chemistry Products PHBR Slides received FDA 510(k) clearance on 2021-08-13, under 510(k) number K210858.

Who is the listed applicant for VITROS Chemistry Products PHBR Slides?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Chemistry Products PHBR Slides?

The FDA product code for VITROS Chemistry Products PHBR Slides is DLZ.

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Fonte oficial

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