510(k) Report

Devices descending from K063664

1 later device reach Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.20240—