Cleared Traditional

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

K071210 · Biomedical Diagnostics (Bmd) SA · Immunology
Dec 2007
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K071210 is an FDA 510(k) clearance for the MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006, a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on December 19, 2007, 232 days after receiving the submission on May 1, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K071210 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2007
Decision Date December 19, 2007
Days to Decision 232 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKO — Anti-rnp Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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