Delfia Triiodothyronine (T3) Kit
510(k) K883810
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883810 | Date2 Dec 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CDP
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1710
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Delfia Triiodothyronine (T3) Kit is a radioimmunoassay device for measuring total triiodothyronine. It is classified as a clinical chemistry device. The kit is used for in vitro diagnostic purposes.
The device is supplied as a kit and is intended for single-use. It is regulated under the product code CDP and has been cleared by the FDA under the 510(k) clearance process, with the clearance number K883810. The device is stored at a location with the address 800 Centennial Ave, Piscataway, NJ 08854.
Other devices from Pharmacia, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Delfia T3 Kit used for?
The Delfia T3 Kit is used for measuring total triiodothyronine for in vitro diagnostic purposes, specifically in clinical chemistry.
Is the Delfia T3 Kit supplied as a single-use device?
Yes, the Delfia T3 Kit is intended for single-use and is supplied as a kit.
How is the Delfia T3 Kit regulated?
The Delfia T3 Kit is regulated under the product code CDP and has been cleared by the FDA under the 510(k) clearance process.