K090563

Substantially Equivalent

HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)

Applicant: Instrumentation Laboratory CO
Product code: GGN
Advisory panel: Hematology
Date received: 2009-03-02
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

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