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FDA 510(k)

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

K-Number: K182063 · 2018-10-30

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2018-10-30
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-10-30 under approval number K182063. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is a medical device that received FDA 510(k) clearance on 2018-10-30. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K182063.

When was VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System approved by the FDA?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System received FDA 510(k) clearance on 2018-10-30, under approval number K182063.

What company makes VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is manufactured by Ortho-Clinical Diagnostics, Inc..

What is the FDA product code for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

The FDA product code for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is JFY.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 29579404 Analytical Chemistry in the Regulatory Science of Medical Devices. Annual review of analytical chemistry (Palo Alto, Calif.) (2018) PMID: 29212782 Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ open (2017)

Other Devices by Ortho-Clinical Diagnostics, Inc.

K160495VITROS® Automation Solutions K161140VITROS Chemistry Products Calibrator Kit 3 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 K190520VITROS XT Chemistry Products GLU-Ca 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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