FDA product code HYG: Glenner'S Stain
HYG is the FDA product code for glenner's stain. 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 HYG. The average 510(k) review took 73 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Glenner'S Stain |
| 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 HYG clearance
Top HYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Occumedics, Inc. | 1 | 1981-01-08 |
Most recent HYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802690 | Occumedics, Inc. | ULTRAPAK CAT. #100-0251 | 1981-01-08 | 73 |
Recalls for HYG devices
openFDA lists no recalls for product code HYG.
Frequently asked questions
What is FDA product code HYG?
HYG is the FDA product code for glenner's stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYG?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HYG?
Across 1 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most HYG clearances?
Occumedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HYG
- Run a recall and safety report across every HYG manufacturer
- Watch product code HYG 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times