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Amy AY2811

by Randox Laboratories, Ltd.

Amy AY2811 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K953211 on 21 Jun 1996 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273200584), 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) K953211

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 Number05055273200584 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953211 Date21 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953211 decided 21 Jun 1996 Active
  • FDA GUDID UDI-DI 05055273200584 listed 9 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2923-2020 FDA Class II initiated 10 Jul 2020

    Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

Timeline

3 dated events

  1. Cleared FDA 510(k) K953211
  2. Listed FDA GUDID 05055273200584
  3. Recall initiated FDA recalls Z-2923-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amy
Generic name
Alpha-amylase isoenzyme IVD, reagent
Model / Ref / Catalog
AY2811
Primary DI / UDI-DI
05055273200584
510(k) Number
FDA product code
CIJ
GMDN term
Alpha-amylase isoenzyme IVD, reagent
Device class
Class II
Regulation number
862.1070
GUDID distribution status
In Commercial Distribution

Related devices

Category: Amylase isoenzyme IVD, reagent

Cleared under the same submission (K953211)

and 1 more cleared under K953211

Similar devices

Other devices filed under FDA product code CIJ (Saccharogenic, Amylase).

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)