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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 K023410
Device Name VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
Applicant
MAINE STANDARDS CO.
765 ROOSEVELT TRAIL
SUITE 9A
WINDHAM,  ME  04062 -5365
Applicant Contact CHRISTINE BEACH
Correspondent
MAINE STANDARDS CO.
765 ROOSEVELT TRAIL
SUITE 9A
WINDHAM,  ME  04062 -5365
Correspondent Contact CHRISTINE BEACH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/10/2002
Decision Date 01/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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