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FDA 510(k)

VITROS XT Chemistry Products UREA-CREA Slides

K-Number: K190326 · 2019-03-14

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2019-03-14
Product CodeCDN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS XT Chemistry Products UREA-CREA Slides 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 2019-03-14 under 510(k) number K190326. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS XT Chemistry Products UREA-CREA Slides?

VITROS XT Chemistry Products UREA-CREA Slides is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190326.

When did VITROS XT Chemistry Products UREA-CREA Slides receive FDA 510(k) clearance?

VITROS XT Chemistry Products UREA-CREA Slides received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190326.

Who is the listed applicant for VITROS XT Chemistry Products UREA-CREA Slides?

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 XT Chemistry Products UREA-CREA Slides?

The FDA product code for VITROS XT Chemistry Products UREA-CREA Slides is CDN.

Other records listing Ortho-Clinical Diagnostics, Inc. as applicant

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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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