510(k) K090900

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 by Siemens Healthcare Diagnostics — Product Code DKB

K090900 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771". The FDA issued a decision of Substantially Equivalent on June 1, 2009. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.