K101456

Substantially Equivalent

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

Applicant: Roche Diagnostics
Product code: JIX
Advisory panel: Clinical Chemistry
Date received: 2010-05-26
Decision date: 2010-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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