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Dkk G-427B

by Bioland Technology Ltd.

Dkk G-427B is a Class II device made by Bioland Technology Ltd., cleared under FDA 510(k) K191657 on 20 Mar 2020 and listed in FDA GUDID since 16 Jul 2021 (UDI-DI 06939184627106), 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) K191657

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 Number06939184627106 UDI-DI Date16 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191657 Date20 Mar 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191657 decided 20 Mar 2020 Active
  • FDA GUDID UDI-DI 06939184627106 listed 16 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191657
  2. Listed FDA GUDID 06939184627106

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dkk
Generic name
Glucose monitoring system IVD, home-use
Model / reference
G-427B
Primary DI / UDI-DI
06939184627106
510(k) Number
FDA product code
NBW
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose monitoring system IVD, home-use

Cleared under the same submission (K191657)

and 8 more cleared under K191657

Similar devices

Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).

Other devices from Bioland Technology Ltd.

See all devices from Bioland Technology Ltd. →

Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)