Home / 510(k) Clearances / K190579

510(k) K190579

TD-4183 Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2019
Date Received
March 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Taidoc Technology Corporation

  • K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System (November 19, 2024)
  • K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (June 16, 2022)
  • K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241 (April 5, 2022)
  • K182934 — FORA P100 Blood Pressure Monitoring System (February 12, 2019)
  • K180863 — FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (December 19, 2018)
  • K181675 — FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (December 10, 2018)
  • K181588 — POPS! one Blood Glucose Monitoring System (November 30, 2018)
  • K172733 — TD-1035 Thermometer (October 22, 2018)
  • K173511 — ActiveCare TD-4121 Blood Glucose Monitoring System (July 12, 2018)
  • K172221 — VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM (June 6, 2018)

Other clearances for product code NBW

  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)