EMIT CFA Thyroxine Assay
by Syva Co. 510(k)
Active
510(k) K790686
Overview
The EMIT CFA Thyroxine Assay is an enzyme immunoassay, non-radiolabeled, for total thyroxine measurement. It is classified as a Class II device under special controls and is designed for clinical chemistry applications.
The assay is manufactured by Syva Co. and was cleared by the FDA on May 25, 1979 under 510(k) number K790686. It is regulated under 862.1700 and is not specified as single-use or reusable. No information regarding sterility, MRI safety, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790686 | Date25 May 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1700
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT CFA Thyroxine Assay used for?
The EMIT CFA Thyroxine Assay is an enzyme immunoassay designed for the measurement of total thyroxine in clinical chemistry applications. It provides a non-radiolabeled method for assessing thyroid function.
Is the EMIT CFA Thyroxine Assay single-use or reusable?
The device data does not specify whether the EMIT CFA Thyroxine Assay is single-use or reusable. No information regarding sterility or storage conditions is provided in the available data.
What is the regulatory status of the EMIT CFA Thyroxine Assay?
The EMIT CFA Thyroxine Assay is classified as a Class II device under special controls. It was cleared by the FDA on May 25, 1979 under 510(k) number K790686 and is regulated under 862.1700.
Who manufactures the EMIT CFA Thyroxine Assay?
The EMIT CFA Thyroxine Assay is manufactured by Syva Co., with its address listed as 803 N. Front St. Suite 3, Mchenry, IL 60050. The manufacturer received FDA clearance for this device.