510(k) K042551

MULTI-CHEM CALIBRATOR A by Wako Chemicals USA, Inc. — Product Code JIX

K042551 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "MULTI-CHEM CALIBRATOR A". The FDA issued a decision of Substantially Equivalent on November 16, 2004. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.