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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 K240468
Device Name Alkaline Phosphatase
Applicant
Abbott Laboratories Diagnostics Division
1915 Hurd Dr.
Department Ra11, Bldg. Lc 8 - 4th Floor Ms 8-9
Irving,  TX  75038
Applicant Contact Bryant Tate
Correspondent
Abbott Laboratories Diagnostics Division
1915 Hurd Dr.
Department Ra11, Bldg. Lc 8 - 4th Floor Ms 8-9
Irving,  TX  75038
Correspondent Contact Bryant Tate
Regulation Number862.1050
Classification Product Code
CJE  
Date Received02/20/2024
Decision Date 10/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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