Abbott Imx Ige
by Abbott Laboratories 510(k)
Active
510(k) K895914
Overview
The Abbott Imx Ige is an immunological device classified as an IgE antigen, antiserum, and control. It is designed for use in diagnostic testing procedures within the field of immunology.
This device is regulated under FDA 510(k) clearance, which was granted on November 13, 1989, under the product code DGC. It is a Class II medical device subject to special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895914 | Date13 Nov 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DGC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the Abbott Imx Ige?
The Abbott Imx Ige is designed for use in diagnostic testing procedures within the field of immunology. It functions as an IgE antigen, antiserum, and control to support clinical diagnostic workflows.
What is the regulatory status of this device?
The Abbott Imx Ige is a Class II medical device that received FDA 510(k) clearance on November 13, 1989, under the product code DGC. It is subject to special controls as defined by the FDA.
Under which medical specialty is this device categorized?
This device is categorized under the immunology medical specialty. It is reviewed by the Immunology advisory committee, which oversees products related to immunological diagnostic testing.