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VeriQuick 11012450MD

by Fourstar Group Inc.

VeriQuick 11012450MD is a Class II device made by Fourstar Group Inc., cleared under FDA 510(k) K212418 on 30 Jun 2022 and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 00049696240482), 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) K212418

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 Number00049696240482 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212418 Date30 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212418 decided 30 Jun 2022 Active
  • FDA GUDID UDI-DI 00049696240482 listed 13 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212418
  2. Listed FDA GUDID 00049696240482

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VeriQuick
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / reference
11012450MD
Primary DI / UDI-DI
00049696240482
510(k) Number
FDA product code
LCX
GMDN term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

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