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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 K033056
Device Name BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
Applicant
Diamond Diagnostics, Inc.
331 Fiske St.
Holliston,  MA  01746
Applicant Contact LINDA M STUNDTNER
Correspondent
Diamond Diagnostics, Inc.
331 Fiske St.
Holliston,  MA  01746
Correspondent Contact LINDA M STUNDTNER
Regulation Number862.1770
Classification Product Code
CDS  
Date Received09/29/2003
Decision Date 01/30/2004
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
Predetermined Change
Control Plan Authorized		 No
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