510(k) K934592

EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR by Abaxis, Inc. — Product Code JJG

K934592 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Abaxis, Inc. has at least 10 other 510(k) clearances on record.