Cleared Traditional

OPTILITE C1 INACTIVATOR KIT

K141100 · The Binding Site Group , Ltd. · Immunology

Jul 2014

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K141100 is an FDA 510(k) clearance for the OPTILITE C1 INACTIVATOR KIT, 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 July 18, 2014, 80 days after receiving the submission on April 29, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K141100 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2014
Decision Date	July 18, 2014
Days to Decision	80 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