510(k) Report

Devices descending from K771198

5 later devices reach Lumi-Aggregometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990398PlateletworksArray Medical, Inc.19991—
+1K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…Dade Intl., Inc.19972—
+2K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc.20061—
+2K023761Plateletworks, Models PW-a, PW-CHelena Laboratories20030—
+3K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd.20200—