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Vitros 6912232

by Ortho-Clinical Diagnostics

Vitros 6912232 is a Class II device made by Ortho-Clinical Diagnostics, cleared under FDA 510(k) K252393 on 29 Oct 2025 and listed in FDA GUDID since 30 Dec 2025 (UDI-DI 10758750033522), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K252393

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10758750033522 UDI-DI Date30 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252393 Date29 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252393 decided 29 Oct 2025 Active
  • FDA GUDID UDI-DI 10758750033522 listed 30 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252393
  2. Listed FDA GUDID 10758750033522

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vitros
Generic name
Troponin I IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
6912232
Primary DI / UDI-DI
10758750033522
510(k) Number
FDA product code
MMI
GMDN term
Troponin I IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
862.1215
GUDID distribution status
In Commercial Distribution

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)