# 25-Oh-Vitamin D Mass Spectrometry Test System
> **Product code: PSL** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1840
## Classification
- **FDA Product Code:** PSL
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1840
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PSL)
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