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Thc Control 2 DA3128

by Randox Laboratories, Ltd.

Thc Control 2 DA3128 is a Class I device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K092269 on 8 Apr 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273207965), 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) K092269

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 Number05055273207965 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092269 Date8 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092269 decided 8 Apr 2011 Active
  • FDA GUDID UDI-DI 05055273207965 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092269
  2. Listed FDA GUDID 05055273207965

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thc Control 2
Generic name
Cannabinoid/cannabinoid metabolite IVD, control
Model / Ref / Catalog
DA3128
Primary DI / UDI-DI
05055273207965
510(k) Number
FDA product code
JJX
GMDN term
Cannabinoid/cannabinoid metabolite IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cannabinoid/cannabinoid metabolite IVD, control

Cleared under the same submission (K092269)

Similar devices

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

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)