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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K013119
Device Name VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
Applicant
Maine Standards Co.
765 Roosevelt Trl.
Windham,  ME  04062
Applicant Contact CHRISTINE BEACH
Correspondent
Maine Standards Co.
765 Roosevelt Trl.
Windham,  ME  04062
Correspondent Contact CHRISTINE BEACH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/18/2001
Decision Date 11/16/2001
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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