510(k) Report

Devices descending from K092566

4 later devices reach Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+1K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+2K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV20170—
+2K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—