FDA product code IAE: Hematoxylin, Iron, Weigert'S
IAE is the FDA product code for hematoxylin, iron, weigert's. 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 IAE. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Hematoxylin, Iron, Weigert'S |
| 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 IAE clearance
Top IAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harleco | 1 | 1977-08-22 |
Most recent IAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771524 | Harleco | HISTOCHEMICAL FERRIC IRON SET | 1977-08-22 | 14 |
Recalls for IAE devices
openFDA lists no recalls for product code IAE.
Frequently asked questions
What is FDA product code IAE?
IAE is the FDA product code for hematoxylin, iron, weigert's. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IAE?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IAE?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most IAE clearances?
Harleco (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IAE
- Run a recall and safety report across every IAE manufacturer
- Watch product code IAE 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