Cleared Traditional

BUHLMANN fCAL turbo

K190784 · Buhlmann Laboratories AG · Immunology

Jun 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K190784 is an FDA 510(k) clearance for the BUHLMANN fCAL turbo, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Buhlmann Laboratories AG (Sch?nenbuch, CH). The FDA issued a Cleared decision on June 25, 2019, 90 days after receiving the submission on March 27, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K190784 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2019
Decision Date	June 25, 2019
Days to Decision	90 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.