Home / 510(k) Clearances / K092686

510(k) K092686

ABL90 FLEX SERIES by Radiometer Medical Aps — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2010
Date Received
September 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Radiometer Medical Aps

  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (September 21, 2017)
  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K160153 — ABL90 FLEX PLUS (November 4, 2016)
  • K142898 — ABL800 FLEX with AQURE connectivity (June 17, 2015)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K131988 — ABL90 FLEX ANALYZER (September 17, 2013)
  • K130144 — ABL90 FLEX (July 31, 2013)
  • K123748 — ABL90 FLEX (May 7, 2013)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)

Other clearances for product code CEM

  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K241037 — ABL90 FLEX PLUS System (January 14, 2025)
  • K220396 — EasyStat 300 (September 26, 2023)
  • K230890 — ISE Electrodes (September 8, 2023)
  • K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (October 1, 2020)
  • K121012 — FLEXLAB 3.6, ACCELERATOR A3600 (August 31, 2012)
  • K121040 — SMARTLYTE ELECTROLYTE ANALYZER (August 30, 2012)
  • K112995 — GEM PREMIER 4000 (May 3, 2012)
  • K110520 — BIOLIS 12I (March 23, 2012)
  • K112412 — AU5800(R) CHEMISTRY ANALYZER (December 23, 2011)