Cleared Traditional

HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

K022083 · The Binding Site, Ltd. · Immunology
Jul 2002
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K022083 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE 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 July 16, 2002, 20 days after receiving the submission on June 26, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K022083 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2002
Decision Date July 16, 2002
Days to Decision 20 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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