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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Ammonia
510(k) Number K051114
Device Name SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
Applicant
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Applicant Contact DAVIDE SPADA
Correspondent
Sentinel Ch. Srl
5 Via Principe Eugenio
Milano,  IT 20155
Correspondent Contact DAVIDE SPADA
Regulation Number862.1065
Classification Product Code
JIF  
Subsequent Product Code
JJX  
Date Received05/02/2005
Decision Date 11/25/2005
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
Recalls CDRH Recalls
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