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Equate 677296453

by Walmart Stores

Equate 677296453 is a Class II device made by Walmart Stores, cleared under FDA 510(k) K182328 on 15 May 2019 and listed in FDA GUDID since 24 Jul 2025 (UDI-DI 00194346473571), 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) K182328

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 Number00194346473571 UDI-DI Date24 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182328 Date15 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182328 decided 15 May 2019 Active
  • FDA GUDID UDI-DI 00194346473571 listed 24 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182328
  2. Listed FDA GUDID 00194346473571

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Equate
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Model / reference
677296453
Primary DI / UDI-DI
00194346473571
510(k) Number
FDA product code
LCX
GMDN term
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Cleared under the same submission (K182328)

Similar devices

Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Other devices from Walmart Stores

See all devices from Walmart Stores →

Properties

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