Cleared Traditional

K053383 - FIDIS CELIAC
(FDA 510(k) Clearance)

K053383 · Biomedical Diagnostics (Bmd) SA · Immunology

Mar 2006

Decision

114d

Days

Class 2

Risk

K053383 is an FDA 510(k) clearance for the FIDIS CELIAC, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on March 29, 2006, 114 days after receiving the submission on December 5, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number	K053383 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2005
Decision Date	March 29, 2006
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF