510(k) Report

Devices descending from K991605

3 later devices reach Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112755Abacus 5Diatron U.S., Inc.201201
+1K110381Cell-Dyn Emerald 22 SystemAbbott Laboratories20111—
+2K190294CELL-DYN Emerald 22 AL SystemAbbott Laboratories20190—