Cleared Traditional

FIDIS DSDNA

K060380 · Biomedical Diagnostics (Bmd) SA · Immunology
May 2006
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K060380 is an FDA 510(k) clearance for the FIDIS DSDNA, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on May 2, 2006, 77 days after receiving the submission on February 14, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K060380 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2006
Decision Date May 02, 2006
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

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