Immunetech Total Ige System

FDA 510(k) K032251 · Immunetech Corporation

Substantially Equivalent

510(k) numberK032251

Submission

Device name
Immunetech Total Ige System
Applicant
Immunetech Corporation
Rancho Santa Fe, CA, US
Received
July 22, 2003
Decision date
December 19, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DGC – Ige, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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Questions and answers

When was Immunetech Total Ige System cleared by the FDA?

Immunetech Total Ige System (K032251) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 150 days after the submission was received.

What is the product code of K032251?

The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.