Cleared Traditional

IGD DIAGNOSTIC TEST KITS

K051299 · The Binding Site, Ltd. · Immunology
Nov 2005
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K051299 is an FDA 510(k) clearance for the IGD DIAGNOSTIC TEST KITS, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 23, 2005, 189 days after receiving the submission on May 18, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K051299 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2005
Decision Date November 23, 2005
Days to Decision 189 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CZJ — Igd, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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