Allergans Pharmacia Cap Sys.Rast Ria/Feia

Q: What is the product code of K911903?

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) K911903 · Pharmacia, Inc.

Substantially Equivalent

510(k) numberK911903

Submission

Device name: Allergans Pharmacia Cap Sys.Rast Ria/Feia
Applicant: Pharmacia, Inc.
New Brunswick, NJ, US
Received: April 29, 1991
Decision date: August 12, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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

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K972364	Unicap PhadiatopDHB · Traditional	09/04/1997SE
K972068	Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional	07/03/1997SE
K970420	Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional	06/30/1997SE
K964152	Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional	04/23/1997SE
K962274	Unicap 100DHB · Traditional	09/12/1996SE
K941993	Pharmacia Cap System Phadiatop FeiaDHB · Traditional	01/30/1996SE
K954337	Genotropin MixerFMF · Traditional	11/13/1995SE
K951025	Piston SyringeFMF · Traditional	10/19/1995SE
K952025	RobocapJQW · Traditional	07/26/1995SE

Questions and answers

When was Allergans Pharmacia Cap Sys.Rast Ria/Feia cleared by the FDA?

Allergans Pharmacia Cap Sys.Rast Ria/Feia (K911903) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 105 days after the submission was received.

What is the product code of K911903?

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