EMIT 2000 Phenytoin Assay/Calibrators
by Syva Co. 510(k)
Active
510(k) K913429
Overview
This device is an enzyme immunoassay for diphenylhydantoin (phenytoin), classified under product code DIP and device class II. It is designed for the quantitative measurement of phenytoin in clinical specimens.
The assay is supplied as a reagent system including calibrators for use in laboratory settings. It received FDA 510(k) clearance (K913429) on August 26, 1991, and is manufactured by Syva Co. in Palo Alto, California.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913429 | Date26 Aug 1991 | 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- Withdrawn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
- Full name
- Emit(R) 2000 Phenytoin Assay/Calibrators
- 510(k) Number
- FDA Product Code
- DIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3350
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent