Clearance Summary
NeoLSD MSMS kit received FDA 510(k) clearance under submission number K173829, sponsored by Wallac Oy, A Subsidiary of Perkinelmer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2018-07-18.
- Submission: K173829
- Applicant / Sponsor: Wallac Oy, A Subsidiary of Perkinelmer
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1488
- Decision date: 2018-07-18
Classification & Regulation
This clearance is catalogued under FDA product code PQW and 21 CFR 862.1488, within the Clinical Chemistry review panel as a Class II device.