Cleared Special

HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

K122066 · The Binding Site Group , Ltd. · Immunology
Aug 2012
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K122066 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 30, 2012, 45 days after receiving the submission on July 16, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K122066 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2012
Decision Date August 30, 2012
Days to Decision 45 days
Submission Type Special
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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