510(k) Report

Devices descending from K942822

3 later devices reach CBC-Line Hematology Linearity Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081641Coulter Lin-X Linearity ControlBeckman Coulter, Inc.20091—
+1K960557Calibration Verification Assessment (Cva)Streck Laboratories, Inc.19960—
+2K100790Coulter Lin-X Linearity Control, Model A81196Beckman Coulter, Inc.20100—