Phadebas Rast/Phadezym Rast Allergen Disc
510(k) K873112
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873112 | Date20 Oct 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DHB
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5750
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
This device is a System, Test, Radioallergosorbent (Rast) Immunological, used for the in vitro detection of allergen-specific IgE antibodies in human serum. It is classified under medical specialty Immunology and regulated under regulation number 866.5750.
The device was cleared via the FDA 510(k) pathway under K873112, with a traditional clearance type and substantially equivalent decision. It is manufactured by Pharmacia, Inc., and assigned product code DHB. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical setting is provided in the data.
Other devices from Pharmacia, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC used for?
It is used for the in vitro detection of allergen-specific IgE antibodies in human serum, enabling immunological testing to identify allergic sensitivities through radioallergosorbent (RAST) methodology.
How is the PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC supplied or configured?
The device is supplied as a System, Test, Radioallergosorbent (Rast) Immunological, designed for laboratory use in detecting allergen-specific IgE, though specific formats, kit components, or packaging details are not provided in the authorization data.
Is the PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC sterile or single-use?
The provided data does not specify whether the device is sterile, single-use, or reusable; no information on sterility status or disposal instructions is included in the FDA 510(k) clearance details.