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VITROS XT Chemistry Products UREA-CREA Slides

by Ortho-Clinical Diagnostics, Inc.

510(k) K190326

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190326 Date14 Mar 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CDN
Device Class
Class II
Regulation
21 CFR Part 862.1770
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vitros XT Chemistry Products UREA-CREA Slides are a clinical chemistry device used for the quantitative measurement of urea nitrogen and creatinine. These slides utilize photometric technology to provide diagnostic analysis in a laboratory setting.

This device is supplied for professional use and has received FDA 510K clearance. It is classified as a Class 2 medical device under regulation number 862.1770.

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