Cleared Traditional

HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

K140664 · The Binding Site Group , Ltd. · Immunology
Apr 2014
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K140664 is an FDA 510(k) clearance for the HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 16, 2014, 29 days after receiving the submission on March 18, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.

Submission Details

510(k) Number K140664 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2014
Decision Date April 16, 2014
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5620

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