510(k) Report

Devices descending from K813375

1 later device reach Hematology Calibrator S-Cal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K935720Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemOrtho Diagnostic Systems, Inc.19960—