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Vitros 6199328

by Ortho-Clinical Diagnostics

Vitros 6199328 is a Class II device made by Ortho-Clinical Diagnostics, cleared under FDA 510(k) K231517 on 23 Aug 2023 and listed in FDA GUDID since 20 Jan 2024 (UDI-DI 10758750034635), 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) K231517

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 Number10758750034635 UDI-DI Date20 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231517 Date23 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231517 decided 23 Aug 2023 Active
  • FDA GUDID UDI-DI 10758750034635 listed 20 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231517
  2. Listed FDA GUDID 10758750034635

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  • Withdrawn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
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
6199328
Primary DI / UDI-DI
10758750034635
510(k) Number
FDA product code
JIS
GMDN term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K231517)

Similar devices in this category

Other devices filed under Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)