510(k) Report

Devices descending from K151429

2 later devices reach QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+1K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.20180—