Immuchem Covalent-Coat Ria Kit
by Immuchem Corp. 510(k)
Active
510(k) K830962
Overview
The Immuchem Covalent-Coat Ria Kit is a radioimmunoassay device designed for the detection of Digoxin. It utilizes a rabbit antibody and a coated tube separation method to perform its analysis.
This device is classified as a Class 2 chemistry device under regulation number 862.3320 and product code DPO. It received FDA 510(k) clearance on May 4, 1983, under the traditional pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830962 | Date4 May 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPO
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Immuchem Corp.
Questions
What is the primary function of the Immuchem Covalent-Coat RIA Kit?
This device is a radioimmunoassay kit specifically designed for the detection of Digoxin. It utilizes a rabbit antibody and a coated tube separation method to perform the analysis.
What is the regulatory classification of this device?
The Immuchem Covalent-Coat RIA Kit is classified as a Class 2 chemistry device under regulation number 862.3320. It received FDA 510(k) clearance on May 4, 1983, through the traditional pathway.
Under which medical specialty is this kit categorized?
This device is categorized under the Clinical Toxicology medical specialty, as indicated by the advisory committee description and the associated product code DPO.