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FDA 510(k)

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

K-Number: K231525 · 2023-08-09

ApplicantOrtho Clinical Diagnostics
Decision Date2023-08-09
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2023-08-09 under approval number K231525. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack?

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is a medical device that received FDA 510(k) clearance on 2023-08-09. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K231525.

When was VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack approved by the FDA?

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack received FDA 510(k) clearance on 2023-08-09, under approval number K231525.

What company makes VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack?

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is NIG.

Other Devices by Ortho Clinical Diagnostics

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Related Devices (Code: NIG)

K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc. K200997Lumipulse G CA19-9-NFujirebio Diagnostics,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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