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Gluc-Pap GL364

by Randox Laboratories, Ltd.

Gluc-Pap GL364 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K003346 on 15 Mar 2001 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273203226), 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) K003346

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 Number05055273203226 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK003346 Date15 Mar 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K003346 decided 15 Mar 2001 Active
  • FDA GUDID UDI-DI 05055273203226 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K003346
  2. Listed FDA GUDID 05055273203226

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gluc-Pap
Generic name
Glucose IVD, reagent
Model / Ref / Catalog
GL364
Primary DI / UDI-DI
05055273203226
510(k) Number
FDA product code
CGA
GMDN term
Glucose IVD, reagent
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose IVD, reagent

Cleared under the same submission (K003346)

and 3 more cleared under K003346

Similar devices

Other devices filed under FDA product code CGA (Glucose Oxidase, Glucose).

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)