510(k) K143636

IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material by Siemens Healthcare Diagnostics, Inc. — Product Code JJX

K143636 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material". The FDA issued a decision of Substantially Equivalent on February 25, 2015. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.