510(k) K993853

K-ASSAY MULTI-ANALYTE CALIBRATOR by Kamiya Biomedical Co. — Product Code JIX

K993853 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY MULTI-ANALYTE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 27, 1999. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.