FDA product code HZG: Oil Red O
HZG is the FDA product code for oil red o. 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 HZG. The average 510(k) review took 59 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Oil Red O |
| 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 HZG clearance
Top HZG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electrophoresis Corp. of America | 1 | 1978-08-31 |
Most recent HZG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781122 | Electrophoresis Corp. of America | LIPOPROTEIN STAIN | 1978-08-31 | 59 |
Recalls for HZG devices
openFDA lists no recalls for product code HZG.
Frequently asked questions
What is FDA product code HZG?
HZG is the FDA product code for oil red o. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZG?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZG?
Across 1 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most HZG clearances?
Electrophoresis Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HZG
- Run a recall and safety report across every HZG manufacturer
- Watch product code HZG 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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