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FDA 510(k)

VITROS Immunodiagnostic Products CEA Reagent Pack

K-Number: K231517 · 2023-08-23

ApplicantOrtho Clinical Diagnostics
Decision Date2023-08-23
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products CEA Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2023-08-23 under approval number K231517. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Immunodiagnostic Products CEA Reagent Pack?

VITROS Immunodiagnostic Products CEA Reagent Pack is a medical device that received FDA 510(k) clearance on 2023-08-23. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K231517.

When was VITROS Immunodiagnostic Products CEA Reagent Pack approved by the FDA?

VITROS Immunodiagnostic Products CEA Reagent Pack received FDA 510(k) clearance on 2023-08-23, under approval number K231517.

What company makes VITROS Immunodiagnostic Products CEA Reagent Pack?

VITROS Immunodiagnostic Products CEA Reagent Pack is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immunodiagnostic Products CEA Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products CEA Reagent Pack is DHX.

Other Devices by Ortho Clinical Diagnostics

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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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