English Plaintain Allergen Disc

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

510(k) Number

K862264 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K830664 Active Cleared 9 May 1983

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  FDA 510(k) K854756 Active Cleared 15 May 1986

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  FDA 510(k) K820228 Active Cleared 11 Mar 1982

• Orchard Grass Allergen Disc

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  FDA 510(k) K811565 Active Cleared 25 Jun 1981

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  FDA 510(k) K823504 Active Cleared 28 Jan 1983

See all devices from Immuno Nuclear Corp. →

• What is the English Plaintain Allergen Disc used for in clinical practice?

  The English Plaintain Allergen Disc is part of a Radioallergosorbent Test (RAST) Immunological System, which measures allergen-specific immunoglobulin E (IgE) antibodies. This helps diagnose allergic conditions like asthma and allergies by identifying sensitivities to specific allergens, including English Plantain.

• Is the English Plaintain Allergen Disc intended for single-use or repeated use?

  The English Plaintain Allergen Disc is explicitly labeled as a single-use diagnostic reagent. It is designed for one-time use in laboratory settings to ensure accurate and reliable allergen-specific IgE antibody testing.

• How is the English Plaintain Allergen Disc supplied, and where is it used?

  The disc is supplied as a single-use diagnostic reagent and is intended exclusively for use in laboratory settings. It is part of a larger RAST Immunological System, which requires specialized laboratory equipment and expertise to perform allergen-specific IgE testing.

• What regulatory pathway was followed for the FDA clearance of the English Plaintain Allergen Disc?

  The English Plaintain Allergen Disc received FDA clearance through a Traditional 510(k) process, classified as Substantially Equivalent (SESE) to a predicate device. The clearance number is K862264, and it falls under the Immunology specialty with product code DHB.

• Are there any specific storage instructions or considerations for the English Plaintain Allergen Disc?

  The provided data does not specify storage instructions for the English Plaintain Allergen Disc. However, as a single-use diagnostic reagent, it should be stored according to standard laboratory protocols for immunological reagents—typically in a cool, dry place, protected from light and contamination, until use.