Clearance Summary
Vitamin D 200M Assay for the Topaz System received FDA 510(k) clearance under submission number DEN170019, sponsored by Ab Sciex, LLC. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2017-05-18.
- Submission: DEN170019
- Applicant / Sponsor: Ab Sciex, LLC
- Clearance pathway: Post-NSE
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1840
- Decision date: 2017-05-18
Classification & Regulation
This clearance is catalogued under FDA product code PSL and 21 CFR 862.1840, within the Clinical Chemistry review panel as a Class II device.