510(k) K160202

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) by Siemens Healthcare Diagnostics, Inc. — Product Code LEH

K160202 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)". The FDA issued a decision of Substantially Equivalent on April 27, 2016. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.