DMP — Digoxin Control Serum, Ria Class I
FDA product code DMP covers "Digoxin Control Serum, Ria", 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
- DMP
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- 510(k) Exempt
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K973973 | Boehringer Mannheim | ELECSYS CALLCHECK DIGOXIN | Nov 4, 1997 |
| K953393 | Chimera Research And Chemical | TOX PERFECT A TUBE | Oct 6, 1995 |
| K780889 | Pcl-Ria | DIGOXIN STANDARDS IN HUMAN SERUM | Aug 14, 1978 |
| K770411 | Nuclear Medical Laboratories | DIGI TROL TM-RX & DIGI TROL TM-TX | Mar 16, 1977 |