510(k) K100200

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 by Siemens Healthcare Diagnostics — Product Code LDP

K100200 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.