FDA product code HYD: Fast Red Salt B
HYD is the FDA product code for fast red salt b. 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 HYD. The average 510(k) review took 8 days (median 8).
Classification
| Field | Value |
|---|---|
| Device name | Fast Red Salt B |
| 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 HYD clearance
Top HYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electrophoresis Corp. of America | 1 | 1979-12-18 |
Most recent HYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792549 | Electrophoresis Corp. of America | FAT RED 7B STAIN SET | 1979-12-18 | 8 |
Recalls for HYD devices
openFDA lists no recalls for product code HYD.
Frequently asked questions
What is FDA product code HYD?
HYD is the FDA product code for fast red salt b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYD?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYD?
Across 1 cleared submissions the average was 8 days from receipt to decision (median 8).
Which companies have the most HYD clearances?
Electrophoresis Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYD
- Run a recall and safety report across every HYD manufacturer
- Watch product code HYD 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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