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Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack

by Ortho-Clinical Diagnostics, Inc.

510(k) K983875

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983875 Date14 May 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0525-2014 FDA Class II initiated 9 Oct 2013

    Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LTK
Device Class
Class II
Regulation
21 CFR Part 866.6010
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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