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FDA 510(k)

VITROS XT Chemistry Products GLU-Ca Slides

K-Number: K190520 · 2019-04-03

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2019-04-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS XT Chemistry Products GLU-Ca Slides is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-04-03 under approval number K190520. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS XT Chemistry Products GLU-Ca Slides?

VITROS XT Chemistry Products GLU-Ca Slides is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190520.

When was VITROS XT Chemistry Products GLU-Ca Slides approved by the FDA?

VITROS XT Chemistry Products GLU-Ca Slides received FDA 510(k) clearance on 2019-04-03, under approval number K190520.

What company makes VITROS XT Chemistry Products GLU-Ca Slides?

VITROS XT Chemistry Products GLU-Ca Slides is manufactured by Ortho-Clinical Diagnostics, Inc..

What is the FDA product code for VITROS XT Chemistry Products GLU-Ca Slides?

The FDA product code for VITROS XT Chemistry Products GLU-Ca Slides is CGA.

Other Devices by Ortho-Clinical Diagnostics, Inc.

K160495VITROS® Automation Solutions K161140VITROS Chemistry Products Calibrator Kit 3 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

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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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