FDA product code IAM: Solution, Lugol'S
IAM is the FDA product code for solution, lugol's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IAM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for IAM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Lugol'S |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IAM devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-17.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code IAM?
IAM is the FDA product code for solution, lugol's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IAM?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Have IAM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code IAM
- Run a recall and safety report across every IAM manufacturer
- Watch product code IAM 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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