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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K993723
Device Name CARDIASURE CARDIAC MARKERS CONTROL
Applicant
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact EVY K JOHNSON
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact EVY K JOHNSON
Regulation Number862.1660
Classification Product Code
JJT  
Date Received11/03/1999
Decision Date 11/23/1999
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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