LAW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Theophylline Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CHEM CHEX THEOPHYLLINE CONTROL (K920223) | Streck Laboratories, Inc. | 1992-06-10 |
| MODEL IRC PASSPORT NEBULIZER (K914251) | Invacare Corp. | 1992-01-24 |
| BIOTRACK THEOPHYLLINE QUALITY CONTROLS (K903924) | Biotrack, Inc. | 1990-09-17 |
| THEOPHYLLINE FPIA CONTROLS (K871589) | Sigma Chemical Co. | 1987-06-17 |
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Every clearance here is in the API, with alerts when new ones post.