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H-103 IGG, H-104 IGA, H-105 IGM

K812821 Class II Traditional
Decision Date
1981-10-26
Sponsor / Applicant
Immulok, Inc.

Technical Specification

510(k) Submission ID K812821
Product Code DFZ
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5510
Decision Date 1981-10-26
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

H-103 IGG, H-104 IGA, H-105 IGM received FDA 510(k) clearance under submission number K812821, sponsored by Immulok, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-10-26.

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.