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Alinity 01R1421

by Abbott Laboratories

Alinity 01R1421 is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K050487 on 26 Apr 2005 and listed in FDA GUDID since 10 May 2019 (UDI-DI 00380740153847), active as of 23 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 23 Oct 2026

Documents

510(k) K050487

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380740153847 UDI-DI Date10 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050487 Date26 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050487 decided 26 Apr 2005 Active
  • FDA GUDID UDI-DI 00380740153847 listed 10 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050487
  2. Listed FDA GUDID 00380740153847

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alinity
Generic name
Lipoprotein A IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
01R1421
Primary DI / UDI-DI
00380740153847
510(k) Number
FDA product code
DFC
GMDN term
Lipoprotein A IVD, kit, nephelometry/turbidimetry
Device class
Class II
Regulation number
866.5600
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lipoprotein A IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K050487)

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)