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Calcium (Ca) CA2390

by Randox Laboratories, Ltd.

Calcium (Ca) CA2390 is a medical device (FDA Class II; FDA product code CJY, Azo Dye, Calcium) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K974607 on 2 Feb 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273200881), active as of 22 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K974607

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 Number05055273200881 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974607 Date2 Feb 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974607 decided 2 Feb 1998 Active
  • FDA GUDID UDI-DI 05055273200881 listed 16 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0839-2019 FDA Class II initiated 4 Dec 2018

    Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

Timeline

3 dated events

  1. Cleared FDA 510(k) K974607
  2. Listed FDA GUDID 05055273200881
  3. Recall initiated FDA recalls Z-0839-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Calcium (Ca)
Generic name
Calcium (Ca2+) IVD, reagent
Model / Ref / Catalog
CA2390
Primary DI / UDI-DI
05055273200881
510(k) Number
FDA product code
CJY
GMDN term
Calcium (Ca2+) IVD, reagent
Device class
Class II
Regulation number
862.1145
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calcium (Ca2+) IVD, reagent

Cleared under the same submission (K974607)

Similar devices

Other devices filed under FDA product code CJY (Azo Dye, Calcium).

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)