Specific IgE Fast Test II
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K863967 FDA 510(k)
- FDA Product Code
- DHB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Specific IgE Fast Test II is a radioallergosorbent (RAST) immunological test system used to detect specific immunoglobulin E (IgE) antibodies in patient blood samples. This test helps identify allergic responses to various substances in the environment.
The device is supplied as a test system for immunology laboratory use and is classified as Class II medical device. It is manufactured by 3M Company and received FDA 510(k) clearance on December 22, 1986, with product code DHB. The device is not described as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Specific IgE Fast Test II used for?
The Specific IgE Fast Test II is a radioallergosorbent (RAST) immunological test system used to detect specific immunoglobulin E (IgE) antibodies in patient blood samples, helping identify allergic responses to various environmental substances.
How is the Specific IgE Fast Test II supplied?
The device is supplied as a test system for immunology laboratory use. The data does not specify whether it is single-use or reusable, nor does it provide information about sterility or storage conditions.
What is the regulatory classification of the Specific IgE Fast Test II?
The Specific IgE Fast Test II is classified as a Class II medical device and received FDA 510(k) clearance on December 22, 1986, with product code DHB. It is manufactured by 3M Company and is substantially equivalent to other devices in its class.
What advisory committee reviewed the Specific IgE Fast Test II?
The device was reviewed by the Immunology advisory committee (IM) as part of the FDA clearance process. This committee specializes in immunology devices and provides expert evaluation during the regulatory review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K863967 - SPECIFIC IGE FAST(TM) TEST II | FDA 510(k) | 3M Company, SPECIFIC IGE FAST(TM) TEST II (K863967) — FDA 510(k) | Innolitics, SPECIFIC IGE FAST(TM) TEST II (K863967) — FDA 510(k) | Innolitics, ImmunoCAP™ Specific IgE tests - Thermo Fisher Scientific, Allergens, Specific IgE Test - Labcorp
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863967 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K863967 24 fields · synced Sep 27, 2026