Radioimmunoassay, Theophylline
FDA product code LCA · Class II (moderate risk) · 21 CFR 862.3880 · Clinical Toxicology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | Photec Diagnostics, Inc. | 03/24/1988SE |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | Medical & Scientific Designs, Inc. | 01/24/1984SE |
| K821862 | Quanticoat 125 I-Theophylline Radioimm.LCA · Traditional | Kallestad Laboratories, Inc. | 07/06/1982SE |
| K821347 | Bio-Mag Theophylline (125I) Radioimmun.LCA · Traditional | Bioclinical Corp. | 05/28/1982SE |
| K792062 | Theophylline RiassayLCA · Traditional | Ria Diagnostics | 02/25/1980SE |