FDA product code CDB: Porter Silber Hydrazone, 17-Hydroxycorticosteroids
CDB is the FDA product code for porter silber hydrazone, 17-hydroxycorticosteroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CDB, from 2 different applicants. The average 510(k) review took 45 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Porter Silber Hydrazone, 17-Hydroxycorticosteroids |
| Device class | Class I |
| Regulation | 21 CFR 862.1385 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDB clearance
Top CDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hycel, Inc. | 1 | 1978-01-30 |
| Eppendorf-Brinkmann, Inc. | 1 | 1977-02-14 |
Most recent CDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K772426 | Hycel, Inc. | 17-HYDROXY TEST | 1978-01-30 | 34 |
| K761271 | Eppendorf-Brinkmann, Inc. | URIN. L7-OH CORTICOSTEROID T(NON HYDRO) | 1977-02-14 | 56 |
Recalls for CDB devices
openFDA lists no recalls for product code CDB.
Frequently asked questions
What is FDA product code CDB?
CDB is the FDA product code for porter silber hydrazone, 17-hydroxycorticosteroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel.
What device class is CDB?
Class I, regulation 21 CFR 862.1385. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDB?
Across 2 cleared submissions the average was 45 days from receipt to decision (median 45).
Which companies have the most CDB clearances?
Hycel, Inc. (1); Eppendorf-Brinkmann, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CDB
- Run a recall and safety report across every CDB manufacturer
- Watch product code CDB 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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