Cleared Traditional

HUMAN IGD KIT FOR USE ON SPAPLUS

K092450 · The Binding Site · Immunology
Dec 2009
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K092450 is an FDA 510(k) clearance for the HUMAN IGD KIT FOR USE ON SPAPLUS, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by The Binding Site (Los Angeles, US). The FDA issued a Cleared decision on December 28, 2009, 140 days after receiving the submission on August 10, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K092450 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2009
Decision Date December 28, 2009
Days to Decision 140 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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