Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITROS XT Chemistry Products TRIG-CHOL Slides

K-Number: K190490 · 2019-03-27

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2019-03-27
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS XT Chemistry Products TRIG-CHOL Slides is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-27 under approval number K190490. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS XT Chemistry Products TRIG-CHOL Slides?

VITROS XT Chemistry Products TRIG-CHOL Slides is a medical device that received FDA 510(k) clearance on 2019-03-27. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190490.

When was VITROS XT Chemistry Products TRIG-CHOL Slides approved by the FDA?

VITROS XT Chemistry Products TRIG-CHOL Slides received FDA 510(k) clearance on 2019-03-27, under approval number K190490.

What company makes VITROS XT Chemistry Products TRIG-CHOL Slides?

VITROS XT Chemistry Products TRIG-CHOL Slides is manufactured by Ortho-Clinical Diagnostics, Inc..

What is the FDA product code for VITROS XT Chemistry Products TRIG-CHOL Slides?

The FDA product code for VITROS XT Chemistry Products TRIG-CHOL Slides is CHH.

Other Devices by Ortho-Clinical Diagnostics, Inc.

K160495VITROS® Automation Solutions K161140VITROS Chemistry Products Calibrator Kit 3 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

View all 18 devices →

Related Devices (Code: CHH)

K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPolymer Technology Systems, Inc. K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings K180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc. K203597Cholesterol2Abbott Ireland Diagnostics Division K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A

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.

↑