Cleared Traditional

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS

K122304 · The Binding Site Group , Ltd. · Immunology

Apr 2013

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K122304 is an FDA 510(k) clearance for the HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 15, 2013, 257 days after receiving the submission on August 1, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K122304 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2012
Decision Date	April 15, 2013
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5250