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Walgreens 10170

by Walgreen Co. 5 variants

Walgreens 10170 is a Class II device made by Walgreen Co., cleared under FDA 510(k) K172257 on 22 Dec 2017 and listed in FDA GUDID since 24 Aug 2018 (UDI-DI 00311917198934), 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) K172257

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 Number00311917198934 UDI-DI Date24 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172257 Date22 Dec 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172257 decided 22 Dec 2017 Active
  • FDA GUDID UDI-DI 00311917198934 listed 24 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172257
  2. Listed FDA GUDID 00311917198934

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  • Withdrawn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
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Model / reference
10170
Primary DI / UDI-DI
00311917198934
510(k) Number
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
Size
Length — 5.5 Inch

Related devices

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

Cleared under the same submission (K172257)

and 4 more cleared under K172257

Similar devices

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

Other devices from Walgreen Co.

See all devices from Walgreen Co. →

Properties

  • Single use
  • Over-the-counter
  • Convenience kit
Other properties (12, all answered No)