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Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che

by Ortho-Clinical Diagnostics, Inc.

510(k) K042479

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 NumberK042479 Date6 Jan 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1460-05 FDA Unclassified (pre-2012) initiated 19 Jul 2005

    Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.

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  • Withdrawn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
LCD
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 862.3450
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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