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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K051457
Device Name SENTINEL PLASMAPROTEINS CAL 3X
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 Number862.1150
Classification Product Code
JIX  
Date Received06/02/2005
Decision Date 07/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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