Clearance Summary
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT received FDA 510(k) clearance under submission number K970477, 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 1997-03-10.
- Submission: K970477
- Applicant / Sponsor: Sebia
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1445
- Decision date: 1997-03-10
Classification & Regulation
This clearance is catalogued under FDA product code CFE and 21 CFR 862.1445, within the Clinical Chemistry review panel as a Class II device.