Cleared Traditional

FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

K062183 · The Binding Site, Ltd. · Immunology
Nov 2006
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K062183 is an FDA 510(k) clearance for the FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 21, 2006, 113 days after receiving the submission on July 31, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K062183 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2006
Decision Date November 21, 2006
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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