FDA product code HYO: Hematoxylin Weigert'S
HYO is the FDA product code for hematoxylin weigert's. 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 HYO. The average 510(k) review took 31 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Hematoxylin Weigert'S |
| 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 HYO clearance
Top HYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1983-11-03 |
Most recent HYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833424 | Sigma Chemical Co. | VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 | 1983-11-03 | 31 |
Recalls for HYO devices
openFDA lists no recalls for product code HYO.
Frequently asked questions
What is FDA product code HYO?
HYO is the FDA product code for hematoxylin weigert's. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYO?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYO?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most HYO clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYO
- Run a recall and safety report across every HYO manufacturer
- Watch product code HYO 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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