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Uibc SI250

by Randox Laboratories, Ltd.

Uibc SI250 is a Class I device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K974604 on 6 Jan 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273206180), active as of 22 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 22 Oct 2026

Documents

510(k) K974604

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273206180 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974604 Date6 Jan 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974604 decided 6 Jan 1998 Active
  • FDA GUDID UDI-DI 05055273206180 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974604
  2. Listed FDA GUDID 05055273206180

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Uibc
Generic name
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
Model / Ref / Catalog
SI250
Primary DI / UDI-DI
05055273206180
510(k) Number
FDA product code
JMO
GMDN term
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
Device class
Class I
Regulation number
862.1415
GUDID distribution status
In Commercial Distribution

Related devices

Category: Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Cleared under the same submission (K974604)

Similar devices

Other devices filed under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity).

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

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