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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 K992430
Device Name CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact SCOT D KINGHORN
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact SCOT D KINGHORN
Regulation Number862.1660
Classification Product Code
JJT  
Date Received07/21/1999
Decision Date 08/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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