ABL90 FLEX PLUS System

FDA 510(k) K241037 · Radiometer Medicals Aps

Substantially Equivalent

510(k) numberK241037

Submission

Device name
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
Brønshøj, DK
Received
April 16, 2024
Decision date
January 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CEM – Electrode, Ion Specific, Potassium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1600
Specialty
Clinical Chemistry

Other 510(k)s with product code CEM

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K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional Roche Diagnostics02/12/2026SE
K220396EasyStat 300CEM · Traditional Medica Corporation09/26/2023SE
K230890ISE ElectrodesCEM · Special Randox Laboratories, Ltd.09/08/2023SE
K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional Diamond Diagnostics, Inc.10/01/2020SE
K121012Flexlab 3.6, Accelerator A3600CEM · Traditional Inpeco S.P.A.08/31/2012SE
K121040Smartlyte Electrolyte AnalyzerCEM · Traditional Diamond Diagnostics, Inc.08/30/2012SE
K112995Gem Premier 4000CEM · Traditional Instrumentation Laboratory CO05/03/2012SE
K110520Biolis 12ICEM · Traditional Tokyo Boeki Medisys, Inc.03/23/2012SE
K112412AU5800(R) Chemistry AnalyzerCEM · Traditional Beckman Coulter, Inc.12/23/2011SE
K112408Poly-Chem 90 Ise ModuleCEM · Traditional Polymedco, Inc.11/04/2011SE

More from Polymedco, Inc.

510(k)DeviceDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional 05/01/2026SE
K252475ABL90 FLEX PLUS SystemJGS · Traditional 05/01/2026SE
K252207ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional 04/10/2026SE
K240998ABL90 FLEX PLUS SystemCHL · Traditional 12/13/2024SE

Questions and answers

When was ABL90 FLEX PLUS System cleared by the FDA?

ABL90 FLEX PLUS System (K241037) received a 510(k) decision of Substantially Equivalent on January 14, 2025, 273 days after the submission was received.

What is the product code of K241037?

The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.