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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K142964
Device Name VALIDATE Anemia 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 Number862.1660
Classification Product Code
JJY  
Date Received10/14/2014
Decision Date 04/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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