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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K141728
Device Name ACE CALIBRATOR
Applicant
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Applicant Contact Patricia Dupe
Correspondent
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Correspondent Contact Patricia Dupe
Regulation Number862.1150
Classification Product Code
JIT  
Date Received06/26/2014
Decision Date 07/28/2014
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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