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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 K970976
Device Name CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Applicant Contact SCOT KINGHORN
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Correspondent Contact SCOT KINGHORN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/17/1997
Decision Date 04/02/1997
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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