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FDA 510(k)

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

Número K: K182063 · 2018-10-30

RequerenteOrtho-Clinical Diagnostics, Inc.
Data da decisão2018-10-30
Código do produtoJFY
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System 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 2018-10-30 under 510(k) number K182063. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K182063.

When did VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System receive FDA 510(k) clearance?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182063.

Who is the listed applicant for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

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 CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

The FDA product code for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is JFY.

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Outros registros que listam Ortho-Clinical Diagnostics, Inc. como candidato(a)

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Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: JFY)

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Fonte oficial

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