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Ca CA7941

by Randox Laboratories, Ltd.

Ca CA7941 is a medical device (FDA Class II; FDA product code CIC, Cresolphthalein Complexone, Calcium) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K000375 on 5 Apr 2000 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273200928), 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) K000375

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 Number05055273200928 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000375 Date5 Apr 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000375 decided 5 Apr 2000 Active
  • FDA GUDID UDI-DI 05055273200928 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000375
  2. Listed FDA GUDID 05055273200928

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ca
Generic name
Calcium (Ca2+) IVD, reagent
Model / Ref / Catalog
CA7941
Primary DI / UDI-DI
05055273200928
510(k) Number
FDA product code
CIC
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 (K000375)

Similar devices

Other devices filed under FDA product code CIC (Cresolphthalein Complexone, 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)