Cleared Traditional

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

K103824 · The Binding Site · Immunology
Feb 2012
Decision
424d
Days
Class 2
Risk

About This 510(k) Submission

K103824 is an FDA 510(k) clearance for the HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site (Birmingham West Midlands, GB). The FDA issued a Cleared decision on February 27, 2012, 424 days after receiving the submission on December 30, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K103824 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2010
Decision Date February 27, 2012
Days to Decision 424 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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