FDA product code CHZ: Di (O-Hydroxyphenylimine) Ethane, Calcium
CHZ is the FDA product code for di (o-hydroxyphenylimine) ethane, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CHZ. The average 510(k) review took 60 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Di (O-Hydroxyphenylimine) Ethane, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| 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 CHZ clearance
Top CHZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sclavo, Inc. | 1 | 1984-03-19 |
Most recent CHZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840214 | Sclavo, Inc. | CALCIUM REAGENT SYS | 1984-03-19 | 60 |
Recalls for CHZ devices
openFDA lists no recalls for product code CHZ.
Frequently asked questions
What is FDA product code CHZ?
CHZ is the FDA product code for di (o-hydroxyphenylimine) ethane, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CHZ?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHZ?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most CHZ clearances?
Sclavo, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHZ
- Run a recall and safety report across every CHZ manufacturer
- Watch product code CHZ 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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