Clearance Summary
GSP NEONATAL THYROXINE (T4) received FDA 510(k) clearance under submission number K103484, sponsored by Wallac Oy, A Subsidiary of Perkinelmer, Inc.. 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 2011-04-22.
- Submission: K103484
- Applicant / Sponsor: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 2011-04-22
Classification & Regulation
This clearance is catalogued under FDA product code KLI and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.