Home / 510(k) Clearances / K201551

510(k) K201551

KetoSens BT Blood B-Ketone Monitoring System by I-Sens, Inc. — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
June 9, 2020
Clearance Type
Special
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 I-Sens, Inc.

  • K230625 — ReliOn Premier BLU Blood Glucose Monitoring System (August 10, 2023)
  • K222656 — LDE4 Lancing Device (November 23, 2022)
  • K201394 — CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Gluc (October 5, 2021)
  • K192859 — CareSens S Clear BT Blood Glucose Monitoring System (January 24, 2020)
  • K193590 — CareSens S Fit BT Blood Glucose Monitoring System (January 17, 2020)
  • K192220 — ReliOn Premier Classic Blood Glucose Monitoring System (December 13, 2019)
  • K181273 — GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express (November 1, 2018)
  • K180866 — CareSens S Fit Blood Glucose Monitoring System (August 31, 2018)
  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K171480 — NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitorin (December 13, 2017)

Other clearances for product code JIN

  • K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System (June 5, 2020)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (May 4, 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)