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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2023-08-23 under 510(k) 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. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K231517.

When did VITROS Immunodiagnostic Products CEA Reagent Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for VITROS Immunodiagnostic Products CEA Reagent Pack?

The FDA 510(k) record lists Ortho Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ortho Clinical Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223921Access CEABeckman Coulter, Inc.K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.

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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