FDA product code IEG: Table, Slide Warming
IEG is the FDA product code for table, slide warming. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IEG. The average 510(k) review took 23 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Table, Slide Warming |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IEG clearance
Top IEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immulok, Inc. | 1 | 1981-09-23 |
Most recent IEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812497 | Immulok, Inc. | IMMULIK STAIN PLATE | 1981-09-23 | 23 |
Recalls for IEG devices
openFDA lists no recalls for product code IEG.
Frequently asked questions
What is FDA product code IEG?
IEG is the FDA product code for table, slide warming. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IEG?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IEG?
Across 1 cleared submissions the average was 23 days from receipt to decision (median 23).
Which companies have the most IEG clearances?
Immulok, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IEG
- Run a recall and safety report across every IEG manufacturer
- Watch product code IEG 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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