NXO · Class II · 21 CFR 866.5180

FDA Product Code NXO: Calprotectin, Fecal

The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And Ulcerative Colitis And To Differentiate Ibd From Irritable Bowel Syndrome.

Leading manufacturers include DiaSorin, Inc..

1
Total
1
Cleared
228d
Avg days
2022
Since

List of Calprotectin, Fecal devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Jul 26, 2022
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858
DiaSorin, Inc.
Immunology · 228d

How to use this database

This page lists all FDA 510(k) submissions for Calprotectin, Fecal devices (product code NXO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Immunology FDA review panel. Browse all Immunology devices →