510(k) Report

Devices descending from DEN220028

3 later devices reach Cue COVID-19 Molecular Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253453Metrix COVID Test; Metrix COVID Test ProAptitude Medical Systems, Inc.20260—
+1K253971Visby Medical Flu and COVID-19 TestVisby Medical, Inc.20260—
+1K232643Cue COVID-19 Molecular TestCue Health, Inc.20230—