Fluorescent Immunoassay, Phenobarbital
FDA product code LET · Class II (moderate risk) · 21 CFR 862.3660 · Clinical Toxicology
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901537 | Modified Opus Phenobarbital Test SystemLET · Traditional | Pb Diagnostic Systems, Inc. | 06/12/1990SE |
| K865000 | Immpulse Coated Tube Phenobarbital Assay ReagentsLET · Traditional | Sclavo, Inc. | 02/06/1987SE |
| K842592 | Ames Tda Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 08/17/1984SE |
| K830701 | Stratus Phenobarbital Fluorometric EnzLET · Traditional | American Dade | 05/13/1983SE |
| K821408 | Phenobarbital Fluorescent ImmunoLET · Traditional | American Diagnostic Corp. | 05/24/1982SE |
| K820188 | Phenobarbital AssayLET · Traditional | Syva Co. | 02/05/1982SE |
| K810994 | Ames Tda TM Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
| K802255 | Ames Tda Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 09/26/1980SE |