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510(k) K023362

FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN by Fisher Diagnostics — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2002
Date Received
October 7, 2002
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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  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY (August 12, 2004)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
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  • K850160 — FISHER DIAGNOSTICS LATEST-CRP TEST KIT (April 19, 1985)

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)
  • K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 (September 8, 2003)
  • K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (June 27, 2002)