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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 K123127
Device Name VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
Applicant
Maine Standards Co.
765 Roosevelt Trail
Windham,  ME  04062 -5365
Applicant Contact JAMES W CHAMPLIN
Correspondent
Maine Standards Co.
765 Roosevelt Trail
Windham,  ME  04062 -5365
Correspondent Contact JAMES W CHAMPLIN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/04/2012
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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