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510(k) K020979

Device
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
Applicant
DADE BEHRING, INC.
510(k) number
K020979
Product code
GKP  
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-27
Date received
2002-03-26
Regulation
864.5400
Classification name
Instrument, Coagulation, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
REBECCA S AYASH
Address
P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.2024-08-16
K231031ACL TOP Family 70 SeriesInstrumentation Laboratory Company2023-06-21
K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory CO2016-03-03
K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LASInstrumentation Laboratory CO2015-12-13
K091980ACL TOP 700 LASInstrumentation Laboratory CO2009-09-22
K073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory CO2008-05-04
K063679ACL TOPInstrumentation Laboratory CO2007-01-12
K033414ACL TOP MODEL, TOPInstrumentation Laboratory CO2004-01-12
K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560Dade Behring, Inc.2003-09-08
K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINFisher Diagnostics2002-12-09
K001645SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500Dade Behring, Inc.2000-08-04
K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CBio/Data Corp.2000-07-12
K001145SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000Dade Behring, Inc.2000-05-11
K993299SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500Dade Behring, Inc.1999-12-07
K993174SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000Dade Behring, Inc.1999-11-09

Legacy Summary#

summary

FDA Review#

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