Walgreens 116420

by Walgreen Co.

Walgreens 116420 is a Class I device made by Walgreen Co., cleared under FDA 510(k) K183097 on 10 Jan 2019 and listed in FDA GUDID since 15 Feb 2019 (UDI-DI 00311917207087), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00311917207087 UDI-DI	Date15 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK183097	Date10 Jan 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00311917207087
FDA 510(k) database 510(k) number K183097

Across registries

2 registries list this device

FDA 510(k) K183097 decided 10 Jan 2019 Active
FDA GUDID UDI-DI 00311917207087 listed 15 Feb 2019 Listed

Timeline

2 dated events

10 Jan 2019 Cleared FDA 510(k) K183097
15 Feb 2019 Listed FDA GUDID 00311917207087

Coverage

1 jurisdiction

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Withdrawn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 / reference: 116420

Primary DI / UDI-DI: 00311917207087
510(k) Number: K183097
FDA product code: CEP, LCX
GMDN term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Device class: Class I
Regulation number: 862.1485, 862.1155
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Over-the-counter
Combination product

Other properties (12, all answered No)