510(k) K013548

STANDARD IMAGING IVB 1000 WELL CHAMBER by Standard Imaging, Inc. — Product Code KPT

K013548 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STANDARD IMAGING IVB 1000 WELL CHAMBER". The FDA issued a decision of Substantially Equivalent on November 9, 2001. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.