510(k) Report

Devices descending from K070597

3 later devices reach Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100987Invader Mthfr 677Hologic, Inc.20110—
+1K100496Invader Mthfr 1298Hologic, Inc.20110—
+1K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics20100—