FDA 510(k)

VITROS® Automation Solutions

Número K: K160495 · 2016-10-18

RequerenteOrtho-Clinical Diagnostics, Inc.

Data da decisão2016-10-18

Código do produtoKLI

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITROS® Automation Solutions 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 2016-10-18 under 510(k) number K160495. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITROS® Automation Solutions?

VITROS® Automation Solutions is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K160495.

When did VITROS® Automation Solutions receive FDA 510(k) clearance?

VITROS® Automation Solutions received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160495.

Who is the listed applicant for VITROS® Automation Solutions?

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® Automation Solutions?

The FDA product code for VITROS® Automation Solutions is KLI.

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

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent Pack K210858VITROS Chemistry Products PHBR Slides K191316VITROS XT Chemistry Products ALB-TP Slides K190807VITROS XT Chemistry Products TBIL-ALKP Slides K190520VITROS XT Chemistry Products GLU-Ca Slides K190490VITROS XT Chemistry Products TRIG-CHOL Slides

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