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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 K761261
Device Name ENZYMATIC BUN (RATE) REAGENT KIT
Original Applicant
BECKMAN INSTRUMENTS, INC.
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received12/16/1976
Decision Date 12/29/1976
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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