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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Urea Nitrogen
510(k) Number K040973
Device Name BUN REAGENT
Applicant
GENCHEM, INC.
471 W. LAMBERT RD., SUITE 107
BREA,  CA  92821
Applicant Contact C.C. ALLAIN
Correspondent
GENCHEM, INC.
471 W. LAMBERT RD., SUITE 107
BREA,  CA  92821
Correspondent Contact C.C. ALLAIN
Regulation Number862.1770
Classification Product Code
CDS  
Date Received04/14/2004
Decision Date 12/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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