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Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers

by Ortho-Clinical Diagnostics, Inc.

510(k) K033300

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 NumberK033300 Date5 Nov 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0844-2019 FDA Class II initiated 29 Nov 2018 on shared 510(k) K033300

    A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DDR
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 866.5680
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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