510(k) Report

Devices descending from K181205

3 later devices reach Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20222—
+2K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20221—
+3K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20220—