510(k) K132391

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL by Siemens Helathcare Diagnostics, Inc. — Product Code JJX

K132391 is an FDA 510(k) premarket notification submitted by Siemens Helathcare Diagnostics, Inc. for the device "IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL". The FDA issued a decision of Substantially Equivalent on September 20, 2013. 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 Helathcare Diagnostics, Inc. has at least 1 other 510(k) clearance on record.