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Personal Care 12002

by Delta Brands Inc.

Personal Care 12002 is a Class II device made by Delta Brands Inc., cleared under FDA 510(k) K123050 on 5 Feb 2013 and listed in FDA GUDID since 27 Aug 2021 (UDI-DI 00808829120028), active as of 22 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 22 Oct 2026

Documents

510(k) K123050

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00808829120028 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123050 Date5 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123050 decided 5 Feb 2013 Active
  • FDA GUDID UDI-DI 00808829120028 listed 27 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123050
  2. Listed FDA GUDID 00808829120028

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Personal Care
Generic name
Human chorionic gonadotropin alpha-subunit IVD, calibrator
Model / reference
12002
Primary DI / UDI-DI
00808829120028
510(k) Number
FDA product code
LCX
GMDN term
Human chorionic gonadotropin alpha-subunit IVD, calibrator
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human chorionic gonadotropin alpha-subunit IVD, calibrator

Cleared under the same submission (K123050)

and 8 more cleared under K123050

Similar devices

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

Other devices from Delta Brands Inc.

See all devices from Delta Brands Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)