510(k) K033860

AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR by Wako Chemicals USA, Inc. — Product Code JIT

K033860 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 23, 2004. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.