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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K022767
Device Name RAICHEM LIPID CALIBRATOR
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 Number862.1150
Classification Product Code
JIX  
Date Received08/21/2002
Decision Date 09/03/2002
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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