Fluorescent Immunoassay, Diphenylhydantoin
FDA product code LES · Class II (moderate risk) · 21 CFR 862.3350 · Clinical Toxicology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K865102 | Immpulse Coated Tube Phenytoin Assay ReagentsLES · Traditional | Sclavo, Inc. | 01/13/1987SE |
| K844990 | Syva Advance Emit Phenytoin AssayLES · Traditional | Syva Co. | 01/23/1985SE |
| K831154 | Stratus Phenytoin Fluorometric EnzymeLES · Traditional | American Dade | 05/16/1983SE |
| K820187 | Syva Advance Sys. Emit,(R)-Aed(R) PhenyLES · Traditional | Syva Co. | 02/12/1982SE |
| K813538 | Phenytoin Fluorescent ImmunoassayLES · Traditional | American Diagnostic Corp. | 12/31/1981SE |
| K811025 | Ames Tda TM Phenytoin TestLES · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
| K801736 | Ames Tda TM Phenytoin TestLES · Traditional | Miles Laboratories, Inc. | 08/20/1980SE |