Alkaline Phosphatase2— 510(k) K223317

Name: FDA 510(k) clearance K223317
Creator: U.S. Food and Drug Administration
Published: 2023-07-21

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K223317 for Alkaline Phosphatase2, Substantially Equivalent on 2023-07-21. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2022-10-28
Decision date: 2023-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longsford, IE

Download summary PDF View on FDA.gov ↗

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