Phadebas Rast/Phadezym Rast Allergen Discs
510(k) K845032
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK845032 | Date21 Mar 1985 | 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- Withdrawn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, 1 Oct 2026
The device is a System, Test, Radioallergosorbent (Rast) Immunological, used for the in vitro detection of allergen-specific IgE antibodies in human serum. It consists of allergen-coated discs designed to bind specific IgE from patient samples during immunoassay testing.
The device is supplied as a reagent for use in clinical laboratory settings. It is intended for single-use application in immunological testing procedures. Authorization is based on FDA 510(k) clearance K845032, granted on March 21, 1985, under product code DHB and regulation number 866.5750.
Other devices from Pharmacia, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PHADEBAS RAST/PHADEZYM RAST Allergen Discs device used for?
The device is used for the in vitro detection of allergen-specific IgE antibodies in human serum, enabling immunological testing to identify allergic sensitivities in clinical laboratory settings.
How is the PHADEBAS RAST/PHADEZYM RAST Allergen Discs supplied and intended for use?
The device is supplied as a reagent containing allergen-coated discs and is intended for single-use application in immunoassay procedures, meaning each disc is used once per patient sample to prevent cross-contamination and ensure test accuracy.
What regulatory authorization does the PHADEBAS RAST/PHADEZYM RAST Allergen Discs have?
The device received FDA 510(k) clearance under number K845032 on March 21, 1985, based on a traditional submission demonstrating substantial equivalence to a legally marketed predicate device under product code DHB and regulation 866.5750.