510(k) Report

Devices descending from K140198

2 later devices reach Imdx HSV-1/2 for Abbott M2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc.20180—
+1K142156Seegene Anyplex II HSV-1/2 AssaySeegene20150—