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HUMAN CAERULOPLASMIN KIT

K122965 Class II Traditional
Decision Date
2013-06-03
Sponsor / Applicant
The Binding Site Group , Ltd.

Technical Specification

510(k) Submission ID K122965
Product Code DDB
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5210
Decision Date 2013-06-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

HUMAN CAERULOPLASMIN KIT received FDA 510(k) clearance under submission number K122965, 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 2013-06-03.

Classification & Regulation

This clearance is catalogued under FDA product code DDB and 21 CFR 866.5210, within the Immunology review panel as a Class II device.