Home / 510(k) Clearances / K073377

510(k) K073377

ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) by Instrumentation Laboratory CO — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2008
Date Received
December 3, 2007
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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Other clearances for product code GKP

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  • K033414 — ACL TOP MODEL, TOP (January 12, 2004)
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  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
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