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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K023784
Device Name RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
Applicant
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact JOSE A MONTANEZ
Correspondent
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact JOSE A MONTANEZ
Regulation Number862.1475
Classification Product Code
LBR  
Date Received11/12/2002
Decision Date 12/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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