Cleared Traditional

TRANSFERRIN KIT FOR USE ON THE SPAPLUS

K120236 · The Binding Site Group , Ltd. · Immunology
Feb 2013
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K120236 is an FDA 510(k) clearance for the TRANSFERRIN KIT FOR USE ON THE SPAPLUS, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on February 13, 2013, 384 days after receiving the submission on January 26, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K120236 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2012
Decision Date February 13, 2013
Days to Decision 384 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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