510(k) K884312

ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 by Atomic Products Corp. — Product Code KPT

K884312 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270". The FDA issued a decision of Substantially Equivalent on February 16, 1989. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Atomic Products Corp. has at least 9 other 510(k) clearances on record.