FDA product code GGH: Iron Stains
GGH is the FDA product code for iron stains. 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 GGH. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Iron Stains |
| 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 GGH clearance
Top GGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Device Laboratory, Inc. | 1 | 1988-10-06 |
Most recent GGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884011 | Scientific Device Laboratory, Inc. | SNAP N' STAIN IRON STAIN | 1988-10-06 | 14 |
Recalls for GGH devices
openFDA lists no recalls for product code GGH.
Frequently asked questions
What is FDA product code GGH?
GGH is the FDA product code for iron stains. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is GGH?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGH?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most GGH clearances?
Scientific Device Laboratory, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGH
- Run a recall and safety report across every GGH manufacturer
- Watch product code GGH 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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