Clearance Summary
GSP NEONATALGALT KIT, MODEL 3303-001U received FDA 510(k) clearance under submission number K100101, 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 2010-06-11.
- Submission: K100101
- Applicant / Sponsor: Perkinelmer, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1315
- Decision date: 2010-06-11
Classification & Regulation
This clearance is catalogued under FDA product code KQP and 21 CFR 862.1315, within the Clinical Chemistry review panel as a Class II device.