Fasttech System II

Q: When was Fasttech System II cleared by the FDA?

Fasttech System II (K913892) received a 510(k) decision of Substantially Equivalent on October 2, 1991, 33 days after the submission was received.

Q: What is the product code of K913892?

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) K913892 · 3M Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK913892

Submission

Device name: Fasttech System II
Applicant: 3M Diagnostic Systems, Inc.
Santa Clara, CA, US
Received: August 30, 1991
Decision date: October 2, 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

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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
K913054	3M Anti-Cardiolipin Fast(Tm) TestMID · Traditional	11/27/1991SE
K913653	3M Anti-Dsdna Fast TestLRM · Traditional	11/07/1991SE
K911496	Fasttech System 1LSR · Traditional	06/24/1991SE

Questions and answers

When was Fasttech System II cleared by the FDA?

Fasttech System II (K913892) received a 510(k) decision of Substantially Equivalent on October 2, 1991, 33 days after the submission was received.

What is the product code of K913892?

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