510(k) Report

Devices descending from K033612

10 later devices reach Factor II (Prothrombin) G20210A Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc.20180—
+1K132978Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc.20140—
+1K100943Invader Factor IIHologic, Inc.20110—
+1K082118Xpert Hemosil Factor II & Factor V AssayCepheid20092—
+1K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc.20073—
+2K223046Xpert® FII & FVCepheid®20231—
+2K100987Invader Mthfr 677Hologic, Inc.20110—
+2K100496Invader Mthfr 1298Hologic, Inc.20110—
+2K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics20100—
+3K250218Xpert® FII & FVCepheid20250—