Cleared Traditional

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

K102607 · Biomedical Diagnostics (Bmd) SA · Immunology
Dec 2010
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K102607 is an FDA 510(k) clearance for the FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS, 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 December 3, 2010, 84 days after receiving the submission on September 10, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K102607 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2010
Decision Date December 03, 2010
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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