510(k) Report

Devices descending from K033734

10 later devices reach Lightcycler Instrument Version 1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132978Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc.20140—
+1K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc.20073—
+1K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc.20054—
+2K140426Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC)20141—
+2K131930Jbaids Anthrax Detection KitBiofire Diagnostics, Inc.201301
+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—
+2K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc.20073—
+3K192871B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention20190—