Cleared Traditional

SPAPLUS

K100179 · The Binding Site Group , Ltd. · Immunology
Aug 2010
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K100179 is an FDA 510(k) clearance for the SPAPLUS, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by The Binding Site Group , Ltd. (Los Angele, US). The FDA issued a Cleared decision on August 13, 2010, 204 days after receiving the submission on January 21, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K100179 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2010
Decision Date August 13, 2010
Days to Decision 204 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

Similar Devices — CZW Complement C3, Antigen, Antiserum, Control

All 43
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
K063150 · Thermo Electron OY · Mar 2007
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K061852 · Dade Behring, Inc. · Sep 2006
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc. · May 2005
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
K042494 · Ortho-Clinical Diagnostics · Oct 2004
IBL C3D-CIC EIA TEST
K032796 · Ibl GmbH · Jan 2004
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
K032035 · Beckman Coulter, Inc. · Aug 2003