ALFIS Vitamin D, ALFIS-3 Analyzer— 510(k) K221817

Name: FDA 510(k) clearance K221817
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K221817 for ALFIS Vitamin D, ALFIS-3 Analyzer, Substantially Equivalent on 2023-09-22. Applicant: Immunostics Inc.,. Device class: 2.

Clearance details

Applicant: Immunostics Inc.,
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2022-06-22
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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