FDA product code HYS: Light Green
HYS is the FDA product code for light 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 HYS. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Light 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 HYS clearance
Top HYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-11 |
Most recent HYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842927 | E K Ind., Inc. | LIGHT GREEN SF 1% | 1984-09-11 | 48 |
Recalls for HYS devices
openFDA lists no recalls for product code HYS.
Frequently asked questions
What is FDA product code HYS?
HYS is the FDA product code for light green. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYS?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYS?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most HYS clearances?
E K Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYS
- Run a recall and safety report across every HYS manufacturer
- Watch product code HYS 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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