Cleared Traditional

BINDAZYME CLQ CIC EIA KIT

K031563 · The Binding Site, Ltd. · Immunology
Sep 2003
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K031563 is an FDA 510(k) clearance for the BINDAZYME CLQ CIC EIA KIT, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 10, 2003, 114 days after receiving the submission on May 19, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K031563 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2003
Decision Date September 10, 2003
Days to Decision 114 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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