Clearance Summary
GSP Neonatal Total Galactose kit received FDA 510(k) clearance under submission number K190335, sponsored by 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 2019-11-06.
- Submission: K190335
- Applicant / Sponsor: Perkinelmer, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1310
- Decision date: 2019-11-06
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.