Rapitex RF New
by Behring Diagnostics, Inc. 510(k)
Active
510(k) K903852
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903852 | Date30 Aug 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Rapitex(R) Rf New
- 510(k) Number
- FDA Product Code
- DHR
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5775
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
This device is a system test for rheumatoid factor, classified under product code DHR and medical specialty Immunology. It is a Class II device subject to special controls, as indicated by its FDA 510(k) clearance.
The device was cleared by the FDA via the traditional 510(k) pathway on August 30, 1990, under K903852, following submission by Behring Diagnostics, Inc. It is substantially equivalent to a predicate device and is authorized for distribution in the United States.
Other devices from Behring Diagnostics, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the RAPITEX(R) RF NEW device used for?
The RAPITEX(R) RF NEW is a system test designed to detect rheumatoid factor in patient samples, used within the field of immunology to assist in the diagnosis and monitoring of rheumatoid arthritis and related autoimmune conditions.
How is the RAPITEX(R) RF NEW device supplied and what is its regulatory status?
The device is supplied as a diagnostic test system for laboratory use and received FDA 510(k) clearance through the traditional pathway on August 30, 1990, under K903852, confirming it is substantially equivalent to a legally marketed predicate device.
What classification and product code apply to the RAPITEX(R) RF NEW device?
RAPITEX(R) RF NEW is classified as a Class II medical device under product code DHR, which corresponds to system tests for rheumatoid factor, and is subject to special controls as required by its classification.