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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K162705
Device Name VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
Applicant
MAINE STANDARDS COMPANY LLC
221 US ROUTE 1
CUMBERLAND FORESIDE,  ME  04110
Applicant Contact JAMES CHAMPLIN
Correspondent
MAINE STANDARDS COMPANY LLC
221 US ROUTE 1
CUMBERLAND FORESIDE,  ME  04110
Correspondent Contact JAMES CHAMPLIN
Regulation Number864.5425
Classification Product Code
GGN  
Date Received09/28/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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