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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 K070971
Device Name MODIFICATION TO SENTINEL CLIN CHEM CAL
Applicant
Sentinel Ch. Srl
Via Robert Koch 2
Milan,  IT 20152
Applicant Contact FABIO ROTA
Correspondent
Sentinel Ch. Srl
Via Robert Koch 2
Milan,  IT 20152
Correspondent Contact FABIO ROTA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/06/2007
Decision Date 05/23/2007
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
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