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FDA 510(k)

VITROS XT Chemistry Products ALB-TP Slides

K-Number: K191316 · 2019-06-07

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2019-06-07
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS XT Chemistry Products ALB-TP Slides is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-06-07 under approval number K191316. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS XT Chemistry Products ALB-TP Slides?

VITROS XT Chemistry Products ALB-TP Slides is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K191316.

When was VITROS XT Chemistry Products ALB-TP Slides approved by the FDA?

VITROS XT Chemistry Products ALB-TP Slides received FDA 510(k) clearance on 2019-06-07, under approval number K191316.

What company makes VITROS XT Chemistry Products ALB-TP Slides?

VITROS XT Chemistry Products ALB-TP Slides is manufactured by Ortho-Clinical Diagnostics, Inc..

What is the FDA product code for VITROS XT Chemistry Products ALB-TP Slides?

The FDA product code for VITROS XT Chemistry Products ALB-TP Slides is CIX.

Other Devices by Ortho-Clinical Diagnostics, Inc.

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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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