FDA product code CDN: Urease, Photometric, Urea Nitrogen
CDN is the FDA product code for urease, photometric, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 16 510(k) submissions under CDN, from 14 different applicants. The average 510(k) review took 92 days (median 52). FDA has posted 2 recalls for CDN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urease, Photometric, Urea Nitrogen |
| Device class | Class II |
| Regulation | 21 CFR 862.1770 |
| 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 CDN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 29 |
Compare with all 510(k) review times · Search every CDN clearance
Top CDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | 2 | 2019-03-14 |
| Alfa Wassermann Diagnostic Technologies, Inc. | 2 | 2012-08-10 |
| Hitachi Chemical Diagnostics, Inc. | 1 | 2013-10-28 |
| Alfa Wassermann Diagnostics Technologies, LLC | 1 | 2013-05-21 |
| Cholestech Corp. | 1 | 1997-07-24 |
9 more applicants have CDN clearances. See the full list in Caduvo.
Most recent CDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190326 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products UREA-CREA Slides | 2019-03-14 | 29 |
| K132462 | Hitachi Chemical Diagnostics, Inc. | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | 2013-10-28 | 82 |
| K123322 | Alfa Wassermann Diagnostics Technologies, LLC | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | 2013-05-21 | 207 |
| K113389 | Alfa Wassermann Diagnostic Technologies, Inc. | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | 2012-08-10 | 268 |
| K103615 | Alfa Wassermann Diagnostic Technologies, Inc. | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | 2011-09-08 | 273 |
Recalls for CDN devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CDN?
CDN is the FDA product code for urease, photometric, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel.
What device class is CDN?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDN?
Across 16 cleared submissions the average was 92 days from receipt to decision (median 52).
Which companies have the most CDN clearances?
Ortho-Clinical Diagnostics, Inc. (2); Alfa Wassermann Diagnostic Technologies, Inc. (2); Hitachi Chemical Diagnostics, Inc. (1); Alfa Wassermann Diagnostics Technologies, LLC (1); Cholestech Corp. (1).
Have CDN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code CDN
- Run a recall and safety report across every CDN manufacturer
- Watch product code CDN 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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