PSL — 25-Oh-Vitamin D Mass Spectrometry Test System Class II
Classification Details
- Product Code
- PSL
- Device Class
- Class II
- Regulation Number
- 862.1840
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170019 | ab sciex | Vitamin D 200M Assay for the Topaz System | May 18, 2017 |