FDA product code DKA: Antiserum, Digoxin
DKA is the FDA product code for antiserum, digoxin. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under DKA, from 3 different applicants. The average 510(k) review took 164 days (median 21). FDA has posted 1 recall for DKA devices.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Digoxin |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DKA clearance
Top DKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Diagnostics, Inc. | 1 | 1994-11-22 |
| Clinical Bioresearch | 1 | 1978-04-05 |
| Pcl-Ria, Inc. | 1 | 1978-03-17 |
Most recent DKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934003 | Baxter Diagnostics, Inc. | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | 1994-11-22 | 462 |
| K780498 | Clinical Bioresearch | CBR-DIGOXIN ANTISERUM | 1978-04-05 | 8 |
| K780316 | Pcl-Ria, Inc. | RABBIT ANTIBODY TO DIGOXIN | 1978-03-17 | 21 |
Recalls for DKA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-11-07.
Frequently asked questions
What is FDA product code DKA?
DKA is the FDA product code for antiserum, digoxin. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DKA?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKA?
Across 3 cleared submissions the average was 164 days from receipt to decision (median 21).
Which companies have the most DKA clearances?
Baxter Diagnostics, Inc. (1); Clinical Bioresearch (1); Pcl-Ria, Inc. (1).
Have DKA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-11-07.
Next steps
- Run an FDA pathway report with predicate devices for product code DKA
- Run a recall and safety report across every DKA manufacturer
- Watch product code DKA 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.
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