510(k) Report

Devices descending from K941596

6 later devices reach Remedi HS Drug Profiling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043341Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200…Bio-Rad Laboratories, Inc.200552
+2K113610Ana-Screen with MDSSBio-Rad Laboratories201201
+2K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc.20083—
+3K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics20102—
+4K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc.20121—
+5K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc.20180—