FDA product code HYC: Fast Green
HYC is the FDA product code for fast green. 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 HYC. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Fast Green |
| 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 HYC clearance
Top HYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 1 | 1982-03-26 |
Most recent HYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820634 | Volu Sol Medical Industries | TRICHROME STAIN | 1982-03-26 | 18 |
Recalls for HYC devices
openFDA lists no recalls for product code HYC.
Frequently asked questions
What is FDA product code HYC?
HYC is the FDA product code for fast green. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYC?
Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most HYC clearances?
Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYC
- Run a recall and safety report across every HYC manufacturer
- Watch product code HYC 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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