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HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT

K946070 Class II Traditional
Decision Date
1996-01-30
Sponsor / Applicant
The Binding Site, Ltd.

Technical Specification

510(k) Submission ID K946070
Product Code JZG
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5630
Decision Date 1996-01-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT received FDA 510(k) clearance under submission number K946070, sponsored by The Binding Site, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1996-01-30.

Classification & Regulation

This clearance is catalogued under FDA product code JZG and 21 CFR 866.5630, within the Immunology review panel as a Class II device.