Clearance Summary
Ion PGM Dx System received FDA 510(k) clearance under submission number K170299, sponsored by Life Technologies Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-06-22.
- Submission: K170299
- Applicant / Sponsor: Life Technologies Corporation
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 862.2265
- Decision date: 2017-06-22
Classification & Regulation
This clearance is catalogued under FDA product code PFF and 21 CFR 862.2265, within the Immunology review panel as a Class II device.