FDA product code CDO: Acid, Uric, Uricase (U.V.)
CDO is the FDA product code for acid, uric, uricase (u.v.). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 31 510(k) submissions under CDO, from 24 different applicants. The average 510(k) review took 42 days (median 34). FDA has posted 1 recall for CDO devices.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Uricase (U.V.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDO clearance
Top CDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 4 | 1993-09-27 |
| Sigma Diagnostics, Inc. | 2 | 1999-09-28 |
| Abbott Laboratories | 2 | 1998-06-19 |
| Emd Chemicals, Inc. | 2 | 1982-06-03 |
| Worthington Biochemical Corp. | 2 | 1977-07-11 |
19 more applicants have CDO clearances. See the full list in Caduvo.
Most recent CDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033278 | Randox Laboratories, Ltd. | RANDOX URIC ACID | 2004-02-27 | 140 |
| K992798 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P | 1999-09-28 | 40 |
| K982251 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT | 1998-08-18 | 53 |
| K981766 | Abbott Laboratories | URIC ACID | 1998-06-19 | 31 |
| K981189 | Abbott Laboratories | URIC ACID | 1998-05-07 | 35 |
Recalls for CDO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-03-18.
Frequently asked questions
What is FDA product code CDO?
CDO is the FDA product code for acid, uric, uricase (u.v.). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is CDO?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDO?
Across 31 cleared submissions the average was 42 days from receipt to decision (median 34).
Which companies have the most CDO clearances?
Em Diagnostic Systems, Inc. (4); Sigma Diagnostics, Inc. (2); Abbott Laboratories (2); Emd Chemicals, Inc. (2); Worthington Biochemical Corp. (2).
Have CDO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code CDO
- Run a recall and safety report across every CDO manufacturer
- Watch product code CDO 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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