K162705

Substantially Equivalent

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

Applicant: Maine Standards Company, LLC
Product code: GGN
Advisory panel: Hematology
Date received: 2016-09-28
Decision date: 2017-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland Foreside, ME, US

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