LAW — Theophylline Control Materials Class I
FDA product code LAW covers "Theophylline Control Materials", a Class I medical device regulated under 21 CFR 862.3280. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LAW
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K920223 | streck laboratories | CHEM CHEX THEOPHYLLINE CONTROL | June 10, 1992 |
| K914251 | invacare | MODEL IRC PASSPORT NEBULIZER | January 24, 1992 |
| K903924 | biotrack | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | September 17, 1990 |
| K871589 | sigma chemical | THEOPHYLLINE FPIA CONTROLS | June 17, 1987 |