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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 K091225
Device Name VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
Applicant
MAINE STANDARDS CO.
765 ROOSEVELT TRAIL
WINDHAM,  ME  04062 -5365
Applicant Contact HOLLY CRESSMAN
Correspondent
MAINE STANDARDS CO.
765 ROOSEVELT TRAIL
WINDHAM,  ME  04062 -5365
Correspondent Contact HOLLY CRESSMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/27/2009
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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