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FDA 510(k)

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

K-Number: K221355 · 2022-12-12

ApplicantOrtho Clinical Diagnostics
Decision Date2022-12-12
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS Immuodiagnostic Products CA 125 II Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-12-12 under approval number K221355. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Immuodiagnostic Products CA 125 II Reagent Pack?

VITROS Immuodiagnostic Products CA 125 II Reagent Pack is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K221355.

When was VITROS Immuodiagnostic Products CA 125 II Reagent Pack approved by the FDA?

VITROS Immuodiagnostic Products CA 125 II Reagent Pack received FDA 510(k) clearance on 2022-12-12, under approval number K221355.

What company makes VITROS Immuodiagnostic Products CA 125 II Reagent Pack?

VITROS Immuodiagnostic Products CA 125 II Reagent Pack is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immuodiagnostic Products CA 125 II Reagent Pack?

The FDA product code for VITROS Immuodiagnostic Products CA 125 II Reagent Pack is LTK.

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Related Devices (Code: LTK)

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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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