DMY — Gas Chromatography, Morphine Class II
FDA product code DMY covers "Gas Chromatography, Morphine", a Class II medical device regulated under 21 CFR 862.3640. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DMY
- Device Class
- Class II
- Regulation Number
- 862.3640
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K990409 | roche diagnostics | ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) | April 15, 1999 |