510(k) Report

Devices descending from K970505

2 later devices reach Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc.20061—
+2K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd.20200—