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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 K770315
Device Name BUN, ENZYMATIC
Applicant
ICN PHARMACEUTICALS, INC.
13 MOUNTAINVIEW AVE.
ORANGEBURG,  NY  10962
Correspondent
ICN PHARMACEUTICALS, INC.
13 MOUNTAINVIEW AVE.
ORANGEBURG,  NY  10962
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received02/16/1977
Decision Date 04/05/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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