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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-12-12 under 510(k) 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. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K221355.

When did VITROS Immuodiagnostic Products CA 125 II Reagent Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for VITROS Immuodiagnostic Products CA 125 II 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 Immuodiagnostic Products CA 125 II Reagent Pack?

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

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: LTK)

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.

K240479Access OV MonitorBeckman Coulter, Inc.K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.K200199ADVIA Centaur CA 125IISiemens Healthcare 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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