Home / 510(k) Clearances / K092638

510(k) K092638

FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 by Abbott Diabetes Care, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2010
Date Received
August 27, 2009
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 Abbott Diabetes Care, Inc.

  • K233861 — Libre Rio Continuous Glucose Monitoring System (June 7, 2024)
  • K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash (April 23, 2024)
  • K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash (April 13, 2023)
  • K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous (March 3, 2023)
  • K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System (February 21, 2023)
  • K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System (May 26, 2022)
  • K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System (May 26, 2022)
  • K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (November 22, 2021)
  • K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System (August 11, 2021)
  • K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (July 30, 2021)

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)