K103531

Substantially Equivalent

PRESTIGE 24I; BIOLIS 24I; MGC 240

Applicant: Tokyo Boeki Medisys, Inc.
Product code: CFR
Advisory panel: Clinical Chemistry
Date received: 2010-12-01
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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