510(k) Report

Devices descending from K060489

1 later device reach Dade Pfa-100 Platelet Function Analyzer and Reagents through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd.20200—