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Frida 500001287

by Fridababy, LLC

Frida 500001287 is a Class II device made by Fridababy, LLC, cleared under FDA 510(k) K172257 on 22 Dec 2017 and listed in FDA GUDID since 12 Sep 2024 (UDI-DI 10810028774084), 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 Number10810028774084 UDI-DI Date12 Sep 2024ListedStatusListed 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 10810028774084 listed 12 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172257
  2. Listed FDA GUDID 10810028774084

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Frida
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Model / reference
500001287
Primary DI / UDI-DI
10810028774084
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 (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 Fridababy, LLC

See all devices from Fridababy, LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)