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510(k) K173345

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System by Taidoc Technology Corporation — Product Code JIN

K173345 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2018
Date Received
October 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
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)
  • K190579 — TD-4183 Blood Glucose Monitoring System (June 4, 2019)
  • 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)

Other clearances for product code JIN

  • K201551 — KetoSens BT Blood B-Ketone Monitoring System (September 9, 2020)
  • K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System (June 5, 2020)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (April 21, 2006)
  • K033114 — KETOCHECKS (April 26, 2004)
  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)
  • K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (June 12, 1996)

FDA data resources