510(k) K080404

EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR by Medica Corp. — Product Code JIX

K080404 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR". The FDA issued a decision of Substantially Equivalent on March 13, 2009. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Medica Corp. has at least 10 other 510(k) clearances on record.