Clearance Summary
GSP NEONATAL TOTAL GALACTOSE KIT received FDA 510(k) clearance under submission number K133652, 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 2014-04-28.
- Submission: K133652
- Applicant / Sponsor: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1310
- Decision date: 2014-04-28
Classification & Regulation
This clearance is catalogued under FDA product code JIA and 21 CFR 862.1310, within the Clinical Chemistry review panel as a Class I device.