510(k) K191899

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions by Roche Diagnostics — Product Code CFR

K191899 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions". The FDA issued a decision of Substantially Equivalent on August 16, 2019. 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.