Addit. Allergens to Include Foods for Allerg*Ens

Q: What is the product code of K885269?

The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.

FDA 510(k) K885269 · Dexall Biomedical Labs, Inc.

Substantially Equivalent

510(k) numberK885269

Submission

Device name: Addit. Allergens to Include Foods for Allerg*Ens
Applicant: Dexall Biomedical Labs, Inc.
Gaithersburg, MD, US
Received: December 22, 1988
Decision date: February 7, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DHB – System, Test, Radioallergosorbent (Rast) Immunological
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5750
Specialty: Immunology

Other 510(k)s with product code DHB

510(k)	Device	Applicant	Decision
K260331	IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional	Siemens Healthcare Diagnostics Products, Ltd.	09/04/2026SE
K261027	NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…DHB · Traditional	Hycor Biomedical	07/24/2026SE
K260591	NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…DHB · Traditional	Hycor Biomedical	07/21/2026SE
K260280	NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…DHB · Traditional	Hycor Biomedical	06/18/2026SE
K260059	NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…DHB · Traditional	Hycor Biomedical	05/15/2026SE
K252775	NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…DHB · Traditional	Hycor Biomedical	01/16/2026SE
K252493	NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…DHB · Traditional	Hycor Biomedical	12/23/2025SE
K242531	NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…DHB · Traditional	Hycor Biomedical	04/23/2025SE
K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional	Phadia AB	08/03/2022SE
K220162	Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional	Hycor Biomedical	02/18/2022SE

More from Hycor Biomedical

510(k)	Device	Decision
K875066	Additional Allergens for Allerg*Ens Eia KitDHB · Traditional	01/29/1988SE
K864696	Allerg*Ens Enzyme Immunoassay KitDHB · Traditional	03/17/1987SE
K853607	Allerg-E Ige Enzyme Immunoassay KitDGO · Traditional	11/07/1985SE

Questions and answers

When was Addit. Allergens to Include Foods for Allerg*Ens cleared by the FDA?

Addit. Allergens to Include Foods for Allerg*Ens (K885269) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 47 days after the submission was received.

What is the product code of K885269?

The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.