K093357

Substantially Equivalent

DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D

Applicant: Diamond Diagnostics, Inc.
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2009-10-28
Decision date: 2010-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holliston, MA, US

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