Cleared Traditional

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER

K072889 · The Binding Site, Ltd. · Immunology
Feb 2008
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K072889 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 1, 2008, 114 days after receiving the submission on October 10, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K072889 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2007
Decision Date February 01, 2008
Days to Decision 114 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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