Home / 510(k) Clearances / K241037

510(k) K241037

ABL90 FLEX PLUS System by Radiometer Medicals Aps — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2025
Date Received
April 16, 2024
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 Medicals Aps

  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)

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)
  • 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)
  • K112408 — POLY-CHEM 90 ISE MODULE (November 4, 2011)