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HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

K021081 Class II Traditional
Decision Date
2002-06-17
Sponsor / Applicant
The Binding Site, Ltd.

Technical Specification

510(k) Submission ID K021081
Product Code DFZ
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5510
Decision Date 2002-06-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER received FDA 510(k) clearance under submission number K021081, 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 2002-06-17.

Classification & Regulation

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