Cleared Traditional

FIDIS CONNECTIVE 8

K050286 · Biomedical Diagnostics (Bmd) SA · Immunology
Oct 2005
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K050286 is an FDA 510(k) clearance for the FIDIS CONNECTIVE 8, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on October 3, 2005, 238 days after receiving the submission on February 7, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K050286 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2005
Decision Date October 03, 2005
Days to Decision 238 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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