Cleared Traditional

MININEPH HUMAN B2-MICROGLOBULIN KIT

K014270 · The Binding Site, Ltd. · Immunology
Aug 2002
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K014270 is an FDA 510(k) clearance for the MININEPH HUMAN B2-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 August 15, 2002, 231 days after receiving the submission on December 27, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K014270 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2001
Decision Date August 15, 2002
Days to Decision 231 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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