Application of Emit Aed Assays
by Syva Co. 510(k)
Active
510(k) K801475
Overview
The Application of Emit Aed Assays is an enzyme immunoassay device used for clinical chemistry testing. It is designed to detect and measure specific substances in patient samples through non-radiolabeled immunoassay technology.
This device is supplied by Syva Co. and is intended for laboratory use. It is a Class II medical device with FDA 510(k) clearance (K801475) received on July 8, 1980, and is regulated under product code KLI. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801475 | Date8 Jul 1980 | 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- Withdrawn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