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DHBTI-ALLERGEN IGE FASTSCREEN IV - G13

FDA 510(k)

Class II (US FDA 510(k))

510(k) K883273

by 3m Company

Identifiers

510(k) Number
K883273 FDA 510(k)
FDA Product Code
DHB FDA 510(k)
Models / Variants
g1 FDA 510(k)
G5 FDA 510(k)
G12 FDA 510(k)
G13 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)

This device is a System, Test, Radioallergosorbent (Rast) Immunological test system, as defined by its device type and classification. It is designed for the in vitro detection of specific IgE antibodies to allergens G1, G5, G12, and G13 in human serum.

The device is supplied as a test system for use in clinical laboratory settings. It received FDA 510(k) clearance (K883273) on September 7, 1988, and is classified as a Class II medical device under regulation 866.5750 with product code DHB. The device is intended for use in immunology testing and is not described as sterile, single-use, or reusable in the provided data; no information on MRI safety, storage conditions, or reusability is included in the specifications.

Frequently asked questions

What is the DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) used for?

This device is designed for the in vitro detection of specific IgE antibodies to allergens G1, G5, G12, and G13 in human serum. It is used in clinical laboratory settings for immunology testing to identify allergic sensitization to these specific allergens.

How is the DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) supplied and what is its regulatory status?

The device is supplied as a test system for use in clinical laboratory settings. It received FDA 510(k) clearance (K883273) on September 7, 1988, and is classified as a Class II medical device under regulation 866.5750 with product code DHB.

Is the DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) sterile, single-use, or reusable?

The provided data does not describe the device as sterile, single-use, or reusable. No information on reusability or sterility is included in the specifications, so these characteristics cannot be confirmed from the available data.

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: Dhbti-allergen Ige Fastscreen Iv (G1,G5,G12,G13), K883273 FDA 510 (k) - DHBTI-ALLERGEN IGE FASTSCREEN IV (G1, Dhbti-allergen Ige Fastscreen Iv (g1,g5,g12,g13)… - FDA.report, Dhbti-allergen Ige Fastscreen Iv (G1,G5,G12,G13)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K883273 24 fields · synced Oct 6, 2026