FDA product code CHM: Radioimmunoassay, Total Estrogens In Pregnancy
CHM is the FDA product code for radioimmunoassay, total estrogens in pregnancy. It is a Class I device, regulated under 21 CFR 862.1270 and reviewed by the Clinical Chemistry panel. Devices under CHM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for CHM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Total Estrogens In Pregnancy |
| Device class | Class I |
| Regulation | 21 CFR 862.1270 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CHM devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CHM?
CHM is the FDA product code for radioimmunoassay, total estrogens in pregnancy. It is a Class I device, regulated under 21 CFR 862.1270 and reviewed by the Clinical Chemistry panel.
What device class is CHM?
Class I, regulation 21 CFR 862.1270. Typical premarket route: 510(k) exempt.
Have CHM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CHM
- Run a recall and safety report across every CHM manufacturer
- Watch product code CHM 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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