FDA 510(k)

VITROS Chemistry Products Calibrator Kit 3

Número K: K161140 · 2016-05-20

RequerenteOrtho-Clinical Diagnostics, Inc.

Data da decisão2016-05-20

Código do produtoJIX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITROS Chemistry Products Calibrator Kit 3 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 2016-05-20 under 510(k) number K161140. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITROS Chemistry Products Calibrator Kit 3?

VITROS Chemistry Products Calibrator Kit 3 is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K161140.

When did VITROS Chemistry Products Calibrator Kit 3 receive FDA 510(k) clearance?

VITROS Chemistry Products Calibrator Kit 3 received FDA 510(k) clearance on 2016-05-20, under 510(k) number K161140.

Who is the listed applicant for VITROS Chemistry Products Calibrator Kit 3?

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 Calibrator Kit 3?

The FDA product code for VITROS Chemistry Products Calibrator Kit 3 is JIX.

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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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Fonte oficial

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