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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K193001
Device Name Albumin BCP
Applicant
SENTINEL CH. SpA
Via Robert Koch, 2
Milano,  IT 20152
Applicant Contact Patricia Dupe
Correspondent
SENTINEL CH. SpA
Via Robert Koch, 2
Milano,  IT 20152
Correspondent Contact Patricia Dupe
Regulation Number862.1035
Classification Product Code
CJW  
Date Received10/28/2019
Decision Date 12/19/2019
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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