Fluorescent Immunoassay, Diphenylhydantoin
The Fluorescent Immunoassay for Diphenylhydantoin is a laboratory diagnostic test used to measure serum levels of diphenylhydantoin (phenytoin), an anticonvulsant drug, for therapeutic drug monitoring in patients with epilepsy or other seizure disorders. The device is FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance before marketing. It carries product code LES and is regulated under 21 CFR 862.3350 within the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LES
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K865102 | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS | Jan 13, 1987 | Substantially Equivalent | Sclavo, Inc. |
| K844990 | SYVA ADVANCE EMIT PHENYTOIN ASSAY | Jan 23, 1985 | Substantially Equivalent | Syva Co. |
| K831154 | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | May 16, 1983 | Substantially Equivalent | American Dade |
| K820187 | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | Feb 12, 1982 | Substantially Equivalent | Syva Co. |
| K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY | Dec 31, 1981 | Substantially Equivalent | American Diagnostic Corp. |
| K811025 | AMES TDA TM PHENYTOIN TEST | Apr 29, 1981 | Substantially Equivalent | Miles Laboratories, Inc. |
| K801736 | AMES TDA TM PHENYTOIN TEST | Aug 20, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |