510(k) K101452

CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW by Capintec, Inc. — Product Code KPT

K101452 is an FDA 510(k) premarket notification submitted by Capintec, Inc. for the device "CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW". The FDA issued a decision of Substantially Equivalent on August 9, 2010. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Capintec, Inc. has at least 10 other 510(k) clearances on record.