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FDA 510(k)

VITROS Chemistry Products Calibrator Kit 3

K-Number: K161140 · 2016-05-20

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2016-05-20
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products Calibrator Kit 3 is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K161140. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K161140.

When was VITROS Chemistry Products Calibrator Kit 3 approved by the FDA?

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

What company makes VITROS Chemistry Products Calibrator Kit 3?

VITROS Chemistry Products Calibrator Kit 3 is manufactured by Ortho-Clinical Diagnostics, Inc..

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.

Related PubMed Literature

PMID: 29579404 Analytical Chemistry in the Regulatory Science of Medical Devices. Annual review of analytical chemistry (Palo Alto, Calif.) (2018)

Other Devices by Ortho-Clinical Diagnostics, Inc.

K160495VITROS® Automation Solutions K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides K191316VITROS XT Chemistry Products ALB-TP Slides K190807VITROS XT Chemistry Products TBIL-ALKP Slides K190520VITROS XT Chemistry Products GLU-Ca Slides

View all 18 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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