FDA product code CDL: Berthelot Indophenol, Urea Nitrogen
CDL is the FDA product code for berthelot indophenol, 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 CDL, from 15 different applicants. The average 510(k) review took 36 days (median 36). FDA has posted 1 recall for CDL devices.
Classification
| Field | Value |
|---|---|
| Device name | Berthelot Indophenol, 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 CDL clearance
Top CDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 2 | 1981-02-10 |
| Reagents Applications, Inc. | 1 | 1990-02-16 |
| Stanbio Laboratory | 1 | 1989-07-25 |
| Biochemical Trade, Inc. | 1 | 1987-05-12 |
| Tech-Co, Inc. | 1 | 1987-01-13 |
10 more applicants have CDL clearances. See the full list in Caduvo.
Most recent CDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896845 | Reagents Applications, Inc. | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | 1990-02-16 | 72 |
| K893128 | Stanbio Laboratory | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | 1989-07-25 | 91 |
| K871651 | Biochemical Trade, Inc. | COLORIMETRIC BUN REAGENT KIT | 1987-05-12 | 14 |
| K864742 | Tech-Co, Inc. | UREA NITROGEN(BUN), COLORIMETRIC METHOD | 1987-01-13 | 40 |
| K863889 | U. S. Diagnostics, Inc. | UREA NITROGEN TEST | 1986-11-24 | 49 |
Recalls for CDL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-20.
Frequently asked questions
What is FDA product code CDL?
CDL is the FDA product code for berthelot indophenol, 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 CDL?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDL?
Across 16 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most CDL clearances?
Volu Sol Medical Industries (2); Reagents Applications, Inc. (1); Stanbio Laboratory (1); Biochemical Trade, Inc. (1); Tech-Co, Inc. (1).
Have CDL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code CDL
- Run a recall and safety report across every CDL manufacturer
- Watch product code CDL 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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