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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 K954000
Device Name ROCHE REAGENT FOR BUN
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876 -3771
Applicant Contact MARIA FEIJOO
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876 -3771
Correspondent Contact MARIA FEIJOO
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/25/1995
Decision Date 10/25/1995
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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