FDA product code CCZ: Zimmerman/Norymberski, 17-Ketogenic Steroids
CCZ is the FDA product code for zimmerman/norymberski, 17-ketogenic steroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CCZ. The average 510(k) review took 86 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Zimmerman/Norymberski, 17-Ketogenic Steroids |
| 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 CCZ clearance
Top CCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1976-10-27 |
Most recent CCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760348 | Sigma Chemical Co. | REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 | 1976-10-27 | 86 |
Recalls for CCZ devices
openFDA lists no recalls for product code CCZ.
Frequently asked questions
What is FDA product code CCZ?
CCZ is the FDA product code for zimmerman/norymberski, 17-ketogenic steroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel.
What device class is CCZ?
Class I, regulation 21 CFR 862.1385. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CCZ?
Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most CCZ clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CCZ
- Run a recall and safety report across every CCZ manufacturer
- Watch product code CCZ 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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