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Vitros Immunodiagnostic Products Ca 15-3 Calibrators, Vitros Immunodiagnostic Products Ca 15-3 Reagent Pack

by Ortho-Clinical Diagnostics, Inc.

510(k) K983690

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberK983690 Date2 Feb 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
MOI
Device Class
Class II
Regulation
21 CFR Part 866.6010
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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