510(k) K152961— VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

Substantially Equivalent

Maine Standards Company, LLC

Clearance details

Applicant: Maine Standards Company, LLC
Product code: Code GGN
Advisory panel: Hematology
Date received: 2015-10-07
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland Foreside, ME, US

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