Cleared Traditional

K181012: BUHLMANN fCAL ELISA

K181012 · Buhlmann Laboratories AG · Immunology

Jun 2018

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K181012 is an FDA 510(k) clearance for the BUHLMANN fCAL ELISA, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Buhlmann Laboratories AG (Schonenbuch, CH). The FDA issued a Cleared decision on June 4, 2018, 48 days after receiving the submission on April 17, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K181012 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2018
Decision Date	June 04, 2018
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NXO — Calprotectin, Fecal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5180
Definition	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.