510(k) Report

Devices descending from K760198

2 later devices reach Kit, Platelet Aggregation Reagent (#390) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013596Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)Accumetrics, Inc.200202
+1K992531Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System…Accumetrics, Inc.199903