Kit, Igg, Platelet Associated

FDA product code LLG · Class II (moderate risk) · 21 CFR 864.5425 · Hematology

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K841465General Diagnostics Platelet AntibodyLLG · Traditional General Diagnostics07/02/1984SE
K840257Rapid Immuno-Assay SysLLG · Traditional Applied Polytechnology, Inc.04/19/1984SE

Recalls

RecallProductFirmInitiated
Z-2793-2016 Class IISyngo Plaza picture archiving and communication system (PAC) (PACS) intended to display…Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM… Siemens Medical Solutions USA, Inc08/02/2016Terminated