510(k) DEN170019
DEN170019 is an FDA 510(k) premarket notification submitted by Ab Sciex, LLC for the device "Vitamin D 200M Assay for the Topaz System". The FDA issued a decision of De Novo Granted on May 18, 2017. The device falls under product code PSL (25-Oh-Vitamin D Mass Spectrometry Test System), a Class II device regulated under 21 CFR 862.1840.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 18, 2017
- Date Received
- March 20, 2017
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 25-Oh-Vitamin D Mass Spectrometry Test System
- Device Class
- Class II
- Regulation Number
- 862.1840
- Review Panel
- CH
- Submission Type
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.