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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 K031101
Device Name RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
Applicant
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact JOSE MONTANEZ
Correspondent
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact JOSE MONTANEZ
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/07/2003
Decision Date 06/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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