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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diacetyl-Monoxime, Urea Nitrogen
510(k) Number K771312
Device Name BLOOD UREA NITROGEN (BUN) REAGENT
Applicant
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDW  
Date Received07/18/1977
Decision Date 08/03/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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