510(k) Report

Devices descending from K964506

15 later devices reach Roche Cobas Amplicor Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012966Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc.2002143
+2K092705Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Abbott Molecular, Inc.201027
+2K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp.2003101
+3K132978Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc.20140—
+3K123955Quantstudio DX Real-Time PCR InstrumentLife Technologies Corporation20130—
+3K113319Rotor-Gene Q MDXQIAGEN GmbH201201
+3K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc.20073—
+3K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc.20054—
+4K140426Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC)20141—
+4K131930Jbaids Anthrax Detection KitBiofire Diagnostics, Inc.201301
+4K100987Invader Mthfr 677Hologic, Inc.20110—
+4K100496Invader Mthfr 1298Hologic, Inc.20110—
+4K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics20100—
+4K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc.20073—
+5K192871B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention20190—