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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myeloperoxidase, Immunoassay, System, Test
510(k) Number K050029
Device Name CARDIOMPO TEST
Applicant
Prognostix, Inc.
10265 Carnegie Ave.
Cleveland,  OH  44106
Applicant Contact THOMAS M JACKSON
Correspondent
Prognostix, Inc.
10265 Carnegie Ave.
Cleveland,  OH  44106
Correspondent Contact THOMAS M JACKSON
Regulation Number866.5600
Classification Product Code
NTV  
Subsequent Product Codes
JIS   JJX  
Date Received01/06/2005
Decision Date 05/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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