FDA product code CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen
CDQ is the FDA product code for urease and glutamic dehydrogenase, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 117 510(k) submissions under CDQ, 1 in the last five years, from 72 different applicants. The average 510(k) review took 65 days (median 46). FDA has posted 6 recalls for CDQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urease And Glutamic Dehydrogenase, 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 CDQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 524 |
Compare with all 510(k) review times · Search every CDQ clearance
Top CDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 9 | 1993-09-08 |
| Sigma Diagnostics, Inc. | 5 | 1999-09-28 |
| Abbott Laboratories | 4 | 1998-07-28 |
| Boehringer Mannheim Corp. | 4 | 1989-10-27 |
| Emd Chemicals, Inc. | 4 | 1983-04-05 |
67 more applicants have CDQ clearances. See the full list in Caduvo.
Most recent CDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203771 | Abbott Ireland Diagnostics Division | Urea Nitrogen2 | 2022-05-31 | 524 |
| K140690 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | 2014-09-02 | 167 |
| K110675 | Medica Corp. | EASYRA UREA NITROGEN AND CREATININE REAGENTS | 2011-04-21 | 42 |
| K073295 | Thermofisher Scientific OY | UREA/BUN, SCAL, NORTROL, ABTROL | 2008-05-29 | 188 |
| K070146 | Horiba Abx | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | 2007-10-12 | 269 |
Recalls for CDQ devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-08-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code CDQ?
CDQ is the FDA product code for urease and glutamic dehydrogenase, 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 CDQ?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDQ?
Across 117 cleared submissions the average was 65 days from receipt to decision (median 46).
Which companies have the most CDQ clearances?
Em Diagnostic Systems, Inc. (9); Sigma Diagnostics, Inc. (5); Abbott Laboratories (4); Boehringer Mannheim Corp. (4); Emd Chemicals, Inc. (4).
Have CDQ devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2023-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code CDQ
- Run a recall and safety report across every CDQ manufacturer
- Watch product code CDQ 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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