510(k) Report

Devices descending from K936184

6 later devices reach Vigil PRX Chemistry Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982224Vigil Protein ControlBeckman Coulter, Inc.19980—
+1K974452Vigil Lipid ControlBeckman Instruments, Inc.199731
+1K972819Vigil TDM ControlsBeckman Instruments, Inc.19970—
+2K020521Modification to Vigil Lipid ControlBeckman Coulter, Inc.20020—
+2K983640Synchron Systems Lipid CalibratorBeckman Coulter, Inc.199811
+3K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc.20040—