Immulite Allergy Food Panel FP5E

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Immulite(R) Allergy Food Panel FP5E

510(k) Number

K943194 ↗

FDA Product Code

DGO

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Immulite Allergy Food Panel FP5E used for?

  The Immulite Allergy Food Panel FP5E is an in vitro diagnostic device used for the detection of immunoglobulin E (IgE) antibodies to food antigens. It is designed to assist in the identification of allergic sensitization to specific food allergens and is intended for use in clinical laboratory settings by trained professionals.

• How is the Immulite Allergy Food Panel FP5E supplied and what system is it designed for?

  The device is supplied as a reagent panel specifically designed for use with the Immulite immunoassay system. It is not a standalone test but requires the Immulite system to perform the assay, and it is intended for use by trained laboratory personnel in a clinical setting.

• What regulatory pathway was used for the Immulite Allergy Food Panel FP5E and what is its classification?

  The device received FDA 510(k) clearance under submission K943194 and is classified as a Class II medical device under regulation 866.5510, with product code DGO. This classification reflects its risk level and the regulatory controls required for its safety and effectiveness.