510(k) K220134

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH by Roche Diagnostics — Product Code CFR

K220134 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH". The FDA issued a decision of Substantially Equivalent on September 16, 2022. 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.