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Walgreens 620730

by Walgreen Co.

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) K042280

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00311917084022 UDI-DI Date17 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK042280 Date10 Sep 2004DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Walgreens
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
620730
Primary DI / UDI-DI
00311917084022
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

Related devices

Cleared under the same submission (K042280)

Show all (12)

Other devices from Walgreen Co.

See all devices from Walgreen Co. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No