510(k) K112161

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. by Radiometer Medical Aps — Product Code KHO

K112161 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.