Clearance Summary
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) received FDA 510(k) clearance under submission number K011113, sponsored by Sebia. 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 2001-06-13.
- Submission: K011113
- Applicant / Sponsor: Sebia
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 2001-06-13
Classification & Regulation
This clearance is catalogued under FDA product code CIN and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.