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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K223317
Device Name Alkaline Phosphatase2
Applicant
Abbott Ireland Diagnostics Division
Lisnarnuck
Longsford,  IE
Applicant Contact Julian Braz
Correspondent
Abbott Ireland Diagnostics Division
Lisnarnuck
Longsford,  IE
Correspondent Contact Cherie Lipowsky
Regulation Number862.1050
Classification Product Code
CJE  
Date Received10/28/2022
Decision Date 07/21/2023
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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