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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K041051
Device Name RAICHEM BUN RATE REAGENT (LIQUID)
Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Applicant Contact JAMES J MILLER
Correspondent
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Correspondent Contact JAMES J MILLER
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received04/19/2004
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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