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Alp AP313

by Randox Laboratories, Ltd.

Alp AP313 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K923507 on 3 Dec 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273200331), 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) K923507

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 Number05055273200331 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK923507 Date3 Dec 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K923507 decided 3 Dec 1992 Active
  • FDA GUDID UDI-DI 05055273200331 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K923507
  2. Listed FDA GUDID 05055273200331

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alp
Generic name
Alkaline phosphatase (ALP) isoenzyme IVD, reagent
Model / Ref / Catalog
AP313
Primary DI / UDI-DI
05055273200331
510(k) Number
FDA product code
CJE
GMDN term
Alkaline phosphatase (ALP) isoenzyme IVD, reagent
Device class
Class II
Regulation number
862.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Alkaline phosphatase (ALP) isoenzyme IVD, reagent

Cleared under the same submission (K923507)

and 1 more cleared under K923507

Similar devices

Other devices filed under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes).

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)