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510(k) K160276

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) by Instrumentation Laboratory CO — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2016
Date Received
February 2, 2016
Clearance Type
Special
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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Other clearances for product code GKP

  • K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • 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)
  • K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 (September 8, 2003)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (June 27, 2002)