510(k) K093167

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER by Diagnostica Stago, Inc. — Product Code JPA

K093167 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER". The FDA issued a decision of Substantially Equivalent on December 22, 2009. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.