FDA product code PSM: Refractometer For Donor Testing
PSM is the FDA product code for refractometer for donor testing. It is a Class I device, regulated under 21 CFR 862.2800 and reviewed by the Clinical Chemistry panel. Devices under PSM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
For total protein testing of plasma donors to determine eligibility.
Classification
| Field | Value |
|---|---|
| Device name | Refractometer For Donor Testing |
| Device class | Class I |
| Regulation | 21 CFR 862.2800 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PSM devices
openFDA lists no recalls for product code PSM.
Frequently asked questions
What is FDA product code PSM?
PSM is the FDA product code for refractometer for donor testing. It is a Class I device, regulated under 21 CFR 862.2800 and reviewed by the Clinical Chemistry panel.
What device class is PSM?
Class I, regulation 21 CFR 862.2800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PSM
- Run a recall and safety report across every PSM manufacturer
- Watch product code PSM 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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