Human C5 Rid Kits
510(k) K942326
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942326 | Date24 Aug 1995 | 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- Withdrawn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
- DAY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5240
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Human C5 Rid Kits are diagnostic devices classified as Complement C5, Antigen, Antiserum, and Control. These kits are used in the field of immunology to facilitate the identification and measurement of specific complement proteins.
This device is identified by FDA 510(k) number K942326 and is regulated under 21 CFR 866.5240. It is a Class 2 medical device that received FDA 510(k) clearance on August 24, 1995.
Other devices from Jay H. Geller
Questions
AI-generated answers, 24 Sep 2026
What is the primary clinical use for the Human C5 RID Kits?
These kits are designed for use in the field of immunology to facilitate the identification and measurement of specific complement proteins within a clinical or laboratory setting.
What is the regulatory classification of this device?
The Human C5 RID Kits are classified as a Class 2 medical device under 21 CFR 866.5240. The device received FDA 510(k) clearance on August 24, 1995, under the submission number K942326.
Under which medical specialty are these kits categorized?
The device is categorized under the Immunology medical specialty, as it is specifically designed for the analysis of complement C5 antigens and antisera.