meddevicedb.com FDA Device Reference

HUMAN IGG CSF KIT

K120749 Class II Traditional
Decision Date
2013-05-17
Sponsor / Applicant
The Binding Site Group , Ltd.

Technical Specification

510(k) Submission ID K120749
Product Code CFN
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5510
Decision Date 2013-05-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

HUMAN IGG CSF KIT received FDA 510(k) clearance under submission number K120749, sponsored by The Binding Site Group , 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 2013-05-17.

Classification & Regulation

This clearance is catalogued under FDA product code CFN and 21 CFR 866.5510, within the Immunology review panel as a Class II device.