Instrument, Coagulation

FDA product code KQG · Class II (moderate risk) · 21 CFR 864.5400 · Hematology

14510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K050821Coagcare Anticoagulation Management SystemKQG · Traditional Zycare08/16/2005SE
K021976FIBRON-1, FIBRON-4, Quikcoag, FibronKQG · Traditional Vital Scientific N.V.10/25/2002SE
K992130Pacific Hemostasis Thromboscreen 400CKQG · Traditional Pacific Hemostasis09/03/1999SE
K991321Pacific Hemostasis Thromboscreen 200KQG · Traditional Pacific Hemostasis06/21/1999SE
K983475Hemochron ResponseKQG · Traditional International Technidyne Corp.05/03/1999SE
K902614Elvi 828 Digiclot MultiscanKQG · Traditional Logos Scientific, Inc.11/08/1990SE
K900685Clot 2 Semiautomatic Coagulation AnalyzerKQG · Traditional Texas Intl. Laboratories, Inc.04/16/1990SE
K862047Coagulator (8 Channel)KQG · Traditional Med USA09/29/1986SE
K852492CoagulatorKQG · Traditional Med USA08/13/1985SE
K851169Electra 800 Automatic Coagulation TimerKQG · Traditional Medical Laboratory Automation Systems, Inc.06/24/1985SE
K823131Koagulab 40-A Automated Coagulation SysKQG · Traditional Ortho Diagnostic Systems, Inc.12/09/1982SE
K812906Elvi Biclot 816KQG · Traditional Volu Sol Medical Industries07/22/1982SE
K791587Elvi 810 ClotscannerKQG · Traditional Volu Sol Medical Industries09/17/1979SE
K770914Incubator, Portable, Act-StatKQG · Traditional Thermolyne Corp.08/04/1977SE

Recalls

RecallProductFirmInitiated
Z-1093-2011 Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label…Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification… International Technidyne Corp.11/30/2010Terminated