VITROS Immuodiagnostic Products CA 125 II Reagent Pack— 510(k) K221355

Name: FDA 510(k) clearance K221355
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K221355 for VITROS Immuodiagnostic Products CA 125 II Reagent Pack, Substantially Equivalent on 2022-12-12. Applicant: Ortho Clinical Diagnostics. Device class: 2.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2022-05-10
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgend, GB

Download summary PDF View on FDA.gov ↗

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K143534 — Elecsys CA-125 II assay2015-08-06
K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators2015-05-21

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