510(k) K252488

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

K252488 is an FDA 510(k) premarket notification submitted by Radiometer Medicals Aps for the device "ABL90 FLEX PLUS System". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Radiometer Medicals Aps has at least 4 other 510(k) clearances on record.