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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K070987
Device Name SENTINEL LITHIUM ASSAY
Applicant
SENTINEL CH. SpA
Via Robert Koch, 2
Milano,  IT 20152
Applicant Contact FABIO ROTA
Correspondent
SENTINEL CH. SpA
Via Robert Koch, 2
Milano,  IT 20152
Correspondent Contact FABIO ROTA
Regulation Number862.3560
Classification Product Code
NDW  
Date Received04/06/2007
Decision Date 08/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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