Cleared Traditional

HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

K113349 · The Binding Site Group , Ltd. · Immunology
Jul 2012
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K113349 is an FDA 510(k) clearance for the HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO, a Complement C9, Antigen, Antiserum, Control (Class II — Special Controls, product code DAE), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on July 11, 2012, 240 days after receiving the submission on November 14, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K113349 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2011
Decision Date July 11, 2012
Days to Decision 240 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAE — Complement C9, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240