K093623

Substantially Equivalent

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

Applicant: Instrumentation Laboratory CO
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 2009-11-23
Decision date: 2010-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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