FDA product code HZO: Stain, Ponceau
HZO is the FDA product code for stain, ponceau. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under HZO. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Stain, Ponceau |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HZO clearance
Top HZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1977-10-25 |
Most recent HZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771777 | Sigma Chemical Co. | PONCEAU S CONCENTRATE | 1977-10-25 | 35 |
Recalls for HZO devices
openFDA lists no recalls for product code HZO.
Frequently asked questions
What is FDA product code HZO?
HZO is the FDA product code for stain, ponceau. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZO?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZO?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most HZO clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZO
- Run a recall and safety report across every HZO manufacturer
- Watch product code HZO 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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