Skip to content

Leader 5741855

by Cardinal Health 110, Inc.

Leader 5741855 is a Class II device made by Cardinal Health 110, Inc., cleared under FDA 510(k) K150022 on 7 Aug 2015 and listed in FDA GUDID since 14 Jan 2022 (UDI-DI 00096295141511), 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) K150022

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 Number00096295141511 UDI-DI Date14 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150022 Date7 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150022 decided 7 Aug 2015 Active
  • FDA GUDID UDI-DI 00096295141511 listed 14 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150022
  2. Listed FDA GUDID 00096295141511

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Leader
Generic name
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Model / Ref / Catalog
5741855
Primary DI / UDI-DI
00096295141511
FDA product code
LCX
GMDN term
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical

Cleared under the same submission (K150022)

and 8 more cleared under K150022

Similar devices

Other devices filed under FDA product code LCX (KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER).

Other devices from Cardinal Health 110, Inc.

See all devices from Cardinal Health 110, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)