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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 K062593
Device Name CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
Applicant
Compass Bioscience
1850 Evergreen St.
Duarte,  CA  91010 -2906
Applicant Contact CARTER GRANDJEAN
Correspondent
Compass Bioscience
1850 Evergreen St.
Duarte,  CA  91010 -2906
Correspondent Contact CARTER GRANDJEAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/01/2006
Decision Date 11/22/2006
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
Predetermined Change
Control Plan Authorized		 No
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