FDA product code DMP: Digoxin Control Serum, Ria
DMP is the FDA product code for digoxin control serum, ria. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DMP, from 4 different applicants. The average 510(k) review took 46 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Digoxin Control Serum, Ria |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DMP clearance
Top DMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 1 | 1997-11-04 |
| Chimera Research & Chemical, Inc. | 1 | 1995-10-06 |
| Pcl-Ria, Inc. | 1 | 1978-08-14 |
| Nuclear Medical Laboratories, Inc. | 1 | 1977-03-16 |
Most recent DMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973973 | Boehringer Mannheim Corp. | ELECSYS CALLCHECK DIGOXIN | 1997-11-04 | 15 |
| K953393 | Chimera Research & Chemical, Inc. | TOX PERFECT A TUBE | 1995-10-06 | 84 |
| K780889 | Pcl-Ria, Inc. | DIGOXIN STANDARDS IN HUMAN SERUM | 1978-08-14 | 75 |
| K770411 | Nuclear Medical Laboratories, Inc. | DIGI TROL TM-RX & DIGI TROL TM-TX | 1977-03-16 | 12 |
Recalls for DMP devices
openFDA lists no recalls for product code DMP.
Frequently asked questions
What is FDA product code DMP?
DMP is the FDA product code for digoxin control serum, ria. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is DMP?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DMP?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 45).
Which companies have the most DMP clearances?
Boehringer Mannheim Corp. (1); Chimera Research & Chemical, Inc. (1); Pcl-Ria, Inc. (1); Nuclear Medical Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DMP
- Run a recall and safety report across every DMP manufacturer
- Watch product code DMP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times