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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 K020450
Device Name VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
Applicant
Maine Standards Co.
765 Roosevelt Trl.
Suite 9a
Windham,  ME  04062
Applicant Contact CHRISTINE BEACH
Correspondent
Maine Standards Co.
765 Roosevelt Trl.
Suite 9a
Windham,  ME  04062
Correspondent Contact CHRISTINE BEACH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/11/2002
Decision Date 03/21/2002
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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