510(k) K253490

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions by Roche Diagnostics — Product Code CFR

K253490 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics has at least 10 other 510(k) clearances on record.