Theophylline Control Materials
FDA product code LAW · Class I (low risk) · 21 CFR 862.3280 · Clinical Toxicology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920223 | Chem Chex Theophylline ControlLAW · Traditional | Streck Laboratories, Inc. | 06/10/1992SE |
| K914251 | Model Irc Passport NebulizerLAW · Traditional | Invacare Corp. | 01/24/1992SE |
| K903924 | Biotrack Theophylline Quality ControlsLAW · Traditional | Biotrack, Inc. | 09/17/1990SE |
| K871589 | Theophylline Fpia ControlsLAW · Traditional | Sigma Chemical Co. | 06/17/1987SE |