510(k) K935566

SENSI-CAL AMCO AEPA-1 by Radiometer America, Inc. — Product Code LIE

K935566 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "SENSI-CAL AMCO AEPA-1". The FDA issued a decision of Substantially Equivalent on March 29, 1994. The device falls under product code LIE (Reagent/Device, Inoculum Calibration), a Class II device regulated under 21 CFR 866.1640. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.