510(k) K132664

ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR by Siemens Healthcare Diagnostics, Inc. — Product Code CJW

K132664 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 16, 2013. The device falls under product code CJW (Bromcresol Purple Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.