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Cholestech LDX™ 14874

by Alere San Diego, Inc. 2 variants

Cholestech LDX™ 14874 is a Class I device made by Alere San Diego, Inc., cleared under FDA 510(k) K223179 on 20 Sep 2023 and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 00810039380307), 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) K223179

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 Number00810039380307 UDI-DI Date20 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Dual Track NumberK223179 Date20 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223179 decided 20 Sep 2023 Active
  • FDA GUDID UDI-DI 00810039380307 listed 20 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223179
  2. Listed FDA GUDID 00810039380307

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cholestech LDX™
Generic name
Photometric/spectroscopic immunoassay analyser IVD
Model / Ref / Catalog
14874
Primary DI / UDI-DI
00810039380307
510(k) Number
FDA product code
JJF
GMDN term
Photometric/spectroscopic immunoassay analyser IVD
Device class
Class I
Regulation number
862.2170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Photometric/spectroscopic immunoassay analyser IVD

Cleared under the same submission (K223179)

and 3 more cleared under K223179

Other devices from Alere San Diego, Inc.

See all devices from Alere San Diego, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)