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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 K012120
Device Name VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
Applicant
Maine Standards Co.
765 Roosevelt Trail
Windham,  ME  04062 -5365
Applicant Contact CHRISTINE V BEACH
Correspondent
Maine Standards Co.
765 Roosevelt Trail
Windham,  ME  04062 -5365
Correspondent Contact CHRISTINE V BEACH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/06/2001
Decision Date 08/20/2001
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
Predetermined Change
Control Plan Authorized		 No
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