510(k) K813379

RADIONUCLIDE DOSE CALIBRATOR by Medi Nuclear Corp., Inc. — Product Code KPT

K813379 is an FDA 510(k) premarket notification submitted by Medi Nuclear Corp., Inc. for the device "RADIONUCLIDE DOSE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Medi Nuclear Corp., Inc. has at least 8 other 510(k) clearances on record.