510(k) K060359

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 by Denka Seiken Co., Ltd. — Product Code JIT

K060359 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10". The FDA issued a decision of Substantially Equivalent on April 14, 2006. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Denka Seiken Co., Ltd. has at least 5 other 510(k) clearances on record.