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 a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-14 under approval 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. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190326.
When was VITROS XT Chemistry Products UREA-CREA Slides approved by the FDA?
VITROS XT Chemistry Products UREA-CREA Slides received FDA 510(k) clearance on 2019-03-14, under approval number K190326.
What company makes VITROS XT Chemistry Products UREA-CREA Slides?
VITROS XT Chemistry Products UREA-CREA Slides is manufactured by Ortho-Clinical Diagnostics, Inc..
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 Devices by Ortho-Clinical Diagnostics, Inc.
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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
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.