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GKP — Instrument, Coagulation, Automated Class II

FDA Device Classification

Classification Details

Product Code
GKP
Device Class
Class II
Regulation Number
864.5400
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242127instrumentation laboratory (il)ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOPAugust 16, 2024
K231031instrumentation laboratoryACL TOP Family 70 SeriesJune 21, 2023
K160276instrumentation laboratoryACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOPMarch 3, 2016
K150877instrumentation laboratoryACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOPDecember 13, 2015
K091980instrumentation laboratoryACL TOP 700 LASSeptember 22, 2009
K073377instrumentation laboratoryACL TOP (WITH SYSTEM SOFTWARE V3.0.0)May 4, 2008
K063679instrumentation laboratoryACL TOPJanuary 12, 2007
K033414instrumentation laboratoryACL TOP MODEL, TOPJanuary 12, 2004
K031377dade behringSYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5September 8, 2003
K023362fisher diagnosticsFISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUDecember 9, 2002
K020979dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000June 27, 2002
K001645dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500August 4, 2000
K001891bio/dataMICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CJuly 12, 2000
K001145dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000May 11, 2000
K993299dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500December 7, 1999
K993174dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000November 9, 1999
K992423dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500September 21, 1999
K992763dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500September 21, 1999
K992321dade behringSYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000September 17, 1999
K991101organon teknikaCOAG-A-MATE MAXJune 1, 1999