LES — Fluorescent Immunoassay, Diphenylhydantoin Class II
FDA product code LES covers "Fluorescent Immunoassay, Diphenylhydantoin", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LES
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K865102 | sclavo | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS | January 13, 1987 |
| K844990 | syva | SYVA ADVANCE EMIT PHENYTOIN ASSAY | January 23, 1985 |
| K831154 | american dade | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | May 16, 1983 |
| K820187 | syva | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | February 12, 1982 |
| K813538 | american diagnostic | PHENYTOIN FLUORESCENT IMMUNOASSAY | December 31, 1981 |
| K811025 | miles laboratories | AMES TDA TM PHENYTOIN TEST | April 29, 1981 |
| K801736 | miles laboratories | AMES TDA TM PHENYTOIN TEST | August 20, 1980 |