FDA product code HZS: Safranin
HZS is the FDA product code for safranin. 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 HZS. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Safranin |
| 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 HZS clearance
Top HZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-08-17 |
Most recent HZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842734 | E K Ind., Inc. | SAFRANIN STAIN | 1984-08-17 | 35 |
Recalls for HZS devices
openFDA lists no recalls for product code HZS.
Frequently asked questions
What is FDA product code HZS?
HZS is the FDA product code for safranin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZS?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZS?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most HZS clearances?
E K Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZS
- Run a recall and safety report across every HZS manufacturer
- Watch product code HZS 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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