ALPCO Calprotectin Immunoturbidimetric Assay— 510(k) K220763

Name: FDA 510(k) clearance K220763
Creator: U.S. Food and Drug Administration
Published: 2023-04-13

Substantially Equivalent

ALPCO

FDA 510(k) clearance K220763 for ALPCO Calprotectin Immunoturbidimetric Assay, Substantially Equivalent on 2023-04-13. Applicant: ALPCO. Device class: 2.

Clearance details

Applicant: ALPCO
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2022-03-16
Decision date: 2023-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NH, US

Download summary PDF View on FDA.gov ↗

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