ABL90 FLEX PLUS System

FDA 510(k) K252475 · Radiometer Medicals Aps

Substantially Equivalent

510(k) numberK252475

Submission

Device name
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
Brønshøj, DK
Received
August 7, 2025
Decision date
May 1, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JGS – Electrode, Ion Specific, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

Other 510(k)s with product code JGS

510(k)DeviceApplicantDecision
K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional Abbott Point of Care, Inc.10/27/2023SE
K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional Siemens Healthcare Diagnostics, Inc.07/25/2023SE
K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional Beckman Coulter Laboratory Systems (Suzhou) Co.…07/20/2023SE
K213486GLP systems TrackJGS · Traditional Abbott Laboratories03/10/2022SE
K200403Stat Profile Prime Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation04/14/2020SE
K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional Abbott Point of Care, Inc.02/07/2020SE
K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation07/19/2019SE
K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional Ams Diagnostics06/12/2019SE
K183549GEM Premier ChemSTATJGS · Traditional Instrumentation Laboratory CO02/16/2019SE
K180428Stat Profile Prime Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation08/15/2018SE

More from Nova Biomedical Corporation

510(k)DeviceDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional 05/01/2026SE
K252207ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional 04/10/2026SE
K241037ABL90 FLEX PLUS SystemCEM · Traditional 01/14/2025SE
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 (K252475) received a 510(k) decision of Substantially Equivalent on May 1, 2026, 267 days after the submission was received.

What is the product code of K252475?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.