FDA product code CDA: Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
CDA is the FDA product code for acid, nitrous and nitrosonaphthol, 5-hydroxyindole acetic acid/serotonin. It is a Class I device, regulated under 21 CFR 862.1390 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under CDA, from 3 different applicants. The average 510(k) review took 51 days (median 42). FDA has posted 1 recall for CDA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin |
| Device class | Class I |
| Regulation | 21 CFR 862.1390 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDA clearance
Top CDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 1 | 1995-08-01 |
| Immunotech Corp. | 1 | 1990-10-22 |
| Abbott Laboratories | 1 | 1986-01-17 |
Most recent CDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952817 | Bio-Rad | BIO-RAD URINARY 5-HIAA BY HPLC | 1995-08-01 | 42 |
| K903609 | Immunotech Corp. | SEROTONIN ENZYME IMMUNOASSAY | 1990-10-22 | 74 |
| K854946 | Abbott Laboratories | TDXR 5-HIAA (URINE) | 1986-01-17 | 38 |
Recalls for CDA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CDA?
CDA is the FDA product code for acid, nitrous and nitrosonaphthol, 5-hydroxyindole acetic acid/serotonin. It is a Class I device, regulated under 21 CFR 862.1390 and reviewed by the Clinical Chemistry panel.
What device class is CDA?
Class I, regulation 21 CFR 862.1390. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDA?
Across 3 cleared submissions the average was 51 days from receipt to decision (median 42).
Which companies have the most CDA clearances?
Bio-Rad (1); Immunotech Corp. (1); Abbott Laboratories (1).
Have CDA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CDA
- Run a recall and safety report across every CDA manufacturer
- Watch product code CDA 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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