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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K063852
Device Name ACCESSA CHOLESTEROL PANEL
Applicant
HOME ACCESS HEALTH CORP.
2401 W. HASSELL
SUITE 1510
HOFFMAN ESTATES,  IL  60195 -5200
Applicant Contact KAREN L HANSON
Correspondent
HOME ACCESS HEALTH CORP.
2401 W. HASSELL
SUITE 1510
HOFFMAN ESTATES,  IL  60195 -5200
Correspondent Contact KAREN L HANSON
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Codes
CHH   JGY   LBS  
Date Received12/28/2006
Decision Date 11/09/2007
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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