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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, creatinine
510(k) Number K073634
Device Name MULTIGENT CREATININE (ENZYMATIC) 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 Number862.1225
Classification Product Code
JFY  
Date Received12/26/2007
Decision Date 06/19/2008
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
Recalls CDRH Recalls
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