Cleared Traditional

HUMAN BETA-2 MICROGLOBULIN KIT

K083289 · The Binding Site, Ltd. · Immunology
May 2009
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K083289 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN KIT, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on May 6, 2009, 180 days after receiving the submission on November 7, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K083289 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2008
Decision Date May 06, 2009
Days to Decision 180 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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