FDA product code HZH: Orange G
HZH is the FDA product code for orange g. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under HZH, from 3 different applicants. The average 510(k) review took 22 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Orange G |
| 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 HZH clearance
Top HZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 2 | 1982-08-03 |
| E K Ind., Inc. | 1 | 1984-09-07 |
| Surgipath | 1 | 1981-07-10 |
Most recent HZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842924 | E K Ind., Inc. | ORANGE G, 1% | 1984-09-07 | 44 |
| K822038 | Volu Sol Medical Industries | VOLU-SOL ORANGE G-6(GILLS-MOD | 1982-08-03 | 22 |
| K811825 | Surgipath | ORANGE G-6 | 1981-07-10 | 11 |
| K800323 | Volu Sol Medical Industries | VOLU-SOL ORANGE G-6 STAIN | 1980-02-22 | 10 |
Recalls for HZH devices
openFDA lists no recalls for product code HZH.
Frequently asked questions
What is FDA product code HZH?
HZH is the FDA product code for orange g. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZH?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZH?
Across 4 cleared submissions the average was 22 days from receipt to decision (median 16).
Which companies have the most HZH clearances?
Volu Sol Medical Industries (2); E K Ind., Inc. (1); Surgipath (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZH
- Run a recall and safety report across every HZH manufacturer
- Watch product code HZH 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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