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510(k) K031377

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 by Dade Behring, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2003
Date Received
May 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code GKP

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  • K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP (March 3, 2016)
  • K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP (December 13, 2015)
  • K091980 — ACL TOP 700 LAS (September 22, 2009)
  • K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (May 4, 2008)
  • K063679 — ACL TOP (January 12, 2007)
  • K033414 — ACL TOP MODEL, TOP (January 12, 2004)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (June 27, 2002)