FDA product code PSL: 25-Oh-Vitamin D Mass Spectrometry Test System
PSL is the FDA product code for 25-oh-vitamin d mass spectrometry test system. It is a Class II device, regulated under 21 CFR 862.1840 and reviewed by the Clinical Chemistry panel. Devices under PSL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.
Classification
| Field | Value |
|---|---|
| Device name | 25-Oh-Vitamin D Mass Spectrometry Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1840 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PSL devices
openFDA lists no recalls for product code PSL.
Frequently asked questions
What is FDA product code PSL?
PSL is the FDA product code for 25-oh-vitamin d mass spectrometry test system. It is a Class II device, regulated under 21 CFR 862.1840 and reviewed by the Clinical Chemistry panel.
What device class is PSL?
Class II, regulation 21 CFR 862.1840. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PSL
- Run a recall and safety report across every PSL manufacturer
- Watch product code PSL 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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