510(k) K091617

QMS LIDOCAINE CALIBRATORS, MODEL 0374678 by Thermo Fisher Scientific — Product Code DLJ

K091617 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "QMS LIDOCAINE CALIBRATORS, MODEL 0374678". The FDA issued a decision of Substantially Equivalent on July 17, 2009. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.