510(k) K223317

Device: Alkaline Phosphatase2
Applicant: Abbott Ireland Diagnostics Division
510(k) number: K223317
Product code: CJE
Decision: Substantially Equivalent (SESE)
Decision date: 2023-07-21
Date received: 2022-10-28
Regulation: 862.1050
Classification name: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

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