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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K011126
Device Name RAICHEM CREATININE URINE STANDARD
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
JIT  
Date Received04/13/2001
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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