ABL90 FLEX PLUS System

FDA 510(k) K252488 · Radiometer Medicals Aps

Substantially Equivalent

510(k) numberK252488

Submission

Device name
ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
Brønshøj, DK
Received
August 8, 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
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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K223179Cholestech LDX ™ SystemCGA · Dual Track Alere San Diego, Inc.09/20/2023SE
K223755i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.09/11/2023SE
K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.07/28/2023SE
K223090GEM Premier ChemSTATCGA · Special Instrumentation Laboratory CO01/27/2023SE
K203549Nova Primary Glucose Analyzer SystemCGA · Traditional Nova Biomedical Corporation10/18/2022SE
K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.08/13/2021SE
K200349Stat Profile Prime Plus Analyzer SystemCGA · Traditional Nova Biomedical Corporation03/13/2020SE
K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.02/07/2020SE

More from Abbott Point of Care, Inc.

510(k)DeviceDecision
K252475ABL90 FLEX PLUS SystemJGS · 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 (K252488) received a 510(k) decision of Substantially Equivalent on May 1, 2026, 266 days after the submission was received.

What is the product code of K252488?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.