FDA product code CDR: 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
CDR is the FDA product code for 1-nitroso-2-naphthol (fluorometric), free tyrosine. It is a Class I device, regulated under 21 CFR 862.1730 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CDR. The average 510(k) review took 433 days (median 433).
Classification
| Field | Value |
|---|---|
| Device name | 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine |
| Device class | Class I |
| Regulation | 21 CFR 862.1730 |
| 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 CDR clearance
Top CDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Astoria-Pacific, Inc. | 1 | 1998-03-19 |
Most recent CDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970093 | Astoria-Pacific, Inc. | TYROSINE 50-HOUR REAGENT KIT | 1998-03-19 | 433 |
Recalls for CDR devices
openFDA lists no recalls for product code CDR.
Frequently asked questions
What is FDA product code CDR?
CDR is the FDA product code for 1-nitroso-2-naphthol (fluorometric), free tyrosine. It is a Class I device, regulated under 21 CFR 862.1730 and reviewed by the Clinical Chemistry panel.
What device class is CDR?
Class I, regulation 21 CFR 862.1730. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDR?
Across 1 cleared submissions the average was 433 days from receipt to decision (median 433).
Which companies have the most CDR clearances?
Astoria-Pacific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CDR
- Run a recall and safety report across every CDR manufacturer
- Watch product code CDR 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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