FDA product code CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone
CDZ is the FDA product code for radioimmunoassay, testosterones and dihydrotestosterone. It is a Class I device, regulated under 21 CFR 862.1680 and reviewed by the Clinical Chemistry panel. FDA has cleared 89 510(k) submissions under CDZ, 5 in the last five years, from 48 different applicants. The average 510(k) review took 109 days (median 79); 194 days on average over the last three years. FDA has posted 19 recalls for CDZ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1680 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CDZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 101 |
| 2019 | 4 | 144 |
| 2020 | 1 | 98 |
| 2022 | 1 | 338 |
| 2023 | 1 | 65 |
| 2024 | 2 | 157 |
| 2026 | 1 | 230 |
Compare with all 510(k) review times · Search every CDZ clearance
Top CDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 9 | 2003-10-10 |
| Diagnostic Systems Laboratories, Inc. | 7 | 2000-05-18 |
| Beckman Coulter, Inc. | 4 | 2024-02-08 |
| Siemens Healthcare Diagnostics, Inc. | 4 | 2019-08-28 |
| Leeco Diagnostics, Inc. | 4 | 1986-03-17 |
43 more applicants have CDZ clearances. See the full list in Caduvo.
Most recent CDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252728 | Immunodiagnostic Systems Limited | IDS-iSYS Total Testosterone | 2026-04-15 | 230 |
| K240865 | Immunodiagnostic Systems Limited | IDS-iSYS Free Testosterone | 2024-10-23 | 209 |
| K233480 | Beckman Coulter, Inc. | Access SHBG | 2024-02-08 | 105 |
| K223405 | Beckman Coulter, Inc. | Access Testosterone | 2023-01-13 | 65 |
| K211685 | Roche Diagnostics | Elecsys Testosterone II | 2022-05-06 | 338 |
Recalls for CDZ devices
19 product recalls in 18 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-06-12.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 2 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CDZ?
CDZ is the FDA product code for radioimmunoassay, testosterones and dihydrotestosterone. It is a Class I device, regulated under 21 CFR 862.1680 and reviewed by the Clinical Chemistry panel.
What device class is CDZ?
Class I, regulation 21 CFR 862.1680. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDZ?
Across 89 cleared submissions the average was 109 days from receipt to decision (median 79).
Which companies have the most CDZ clearances?
Diagnostic Products Corp. (9); Diagnostic Systems Laboratories, Inc. (7); Beckman Coulter, Inc. (4); Siemens Healthcare Diagnostics, Inc. (4); Leeco Diagnostics, Inc. (4).
Have CDZ devices been recalled?
Yes: 19 product recalls across 18 recall events; the most recent began 2026-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code CDZ
- Run a recall and safety report across every CDZ manufacturer
- Watch product code CDZ 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 Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times