510(k) Report

Devices descending from K830749

20 later devices reach Platelet Aggregometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp.20052—
+1K051231Verifynow-P2Y12 AssayAccumetrics, Inc.200523
+1K042423Verifynow-Aspirin AssayAccumetrics, Inc.20043—
+1K012701Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc.200201
+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
+1K990398PlateletworksArray Medical, Inc.19991—
+1K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…Dade Intl., Inc.19972—
+1K962426Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp.19964—
+2K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.20160—
+2K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc.201512
+2K122162AggreguideAggredyne, Inc.201311
+2K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH20120—
+2K062025Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc.20070—
+2K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc.20061—
+2K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp.20043—
+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—
+3K181777AggreGuide A-100 ADPAggredyne, Inc.201901
+3K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc.201701