510(k) Report

Devices descending from K993727

2 later devices reach Bindazyme Anti-Dsdna Eia Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.20161—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—