Home / 510(k) Clearances / K213131

510(k) K213131

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system by Roche Diabetes Care GmbH — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2023
Date Received
September 27, 2021
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 Roche Diabetes Care GmbH

  • K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device (November 13, 2023)
  • K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device (November 13, 2023)
  • K213134 — Accu-Chek Solo micropump system with interoperable technology (August 10, 2023)
  • K220849 — Accu-Chek Safe-T-Pro Plus Lancing Device (May 19, 2022)
  • K203711 — IWL2020 Blood Glucose Monitoring System (May 6, 2022)
  • K220608 — Accu-Chek FastClix Blood Lancing System (April 29, 2022)
  • K220364 — Accu-Chek Safe-T-Pro Uno Lancing Device (April 5, 2022)
  • K214022 — Accu-Chek Softclix Blood Lancing System (February 17, 2022)
  • K181131 — Accu-Chek Guide Me Blood Glucose Monitoring System (December 13, 2018)
  • K160944 — ACCU-CHEK Guide Blood Glucose Monitoring System (August 31, 2016)

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)