FDA product code CDW: Diacetyl-Monoxime, Urea Nitrogen
CDW is the FDA product code for diacetyl-monoxime, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 21 510(k) submissions under CDW, from 20 different applicants. The average 510(k) review took 44 days (median 35). FDA has posted 2 recalls for CDW devices.
Classification
| Field | Value |
|---|---|
| Device name | Diacetyl-Monoxime, 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 |
Compare with all 510(k) review times · Search every CDW clearance
Top CDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Research Products Co. | 2 | 1987-04-22 |
| Catachem, Inc. | 1 | 1988-01-05 |
| Boehringer Mannheim Corp. | 1 | 1986-06-27 |
| Sterling Diagnostics, Inc. | 1 | 1986-02-11 |
| Dilab, Inc. | 1 | 1985-06-10 |
15 more applicants have CDW clearances. See the full list in Caduvo.
Most recent CDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874532 | Catachem, Inc. | BLOOD UREA NITROGEN | 1988-01-05 | 63 |
| K871320 | American Research Products Co. | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | 1987-04-22 | 19 |
| K863425 | American Research Products Co. | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | 1986-10-01 | 27 |
| K861775 | Boehringer Mannheim Corp. | TWIN BUN/GLUCOSE | 1986-06-27 | 50 |
| K860419 | Sterling Diagnostics, Inc. | UREA NITROGEN REAGENT SET | 1986-02-11 | 7 |
Recalls for CDW devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-04.
| Year | Recalls |
|---|---|
| 2021 | 2 |
Frequently asked questions
What is FDA product code CDW?
CDW is the FDA product code for diacetyl-monoxime, 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 CDW?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDW?
Across 21 cleared submissions the average was 44 days from receipt to decision (median 35).
Which companies have the most CDW clearances?
American Research Products Co. (2); Catachem, Inc. (1); Boehringer Mannheim Corp. (1); Sterling Diagnostics, Inc. (1); Dilab, Inc. (1).
Have CDW devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2021-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code CDW
- Run a recall and safety report across every CDW manufacturer
- Watch product code CDW 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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