Clearance Summary
HDL-C EIKEN received FDA 510(k) clearance under submission number K813192, sponsored by Syn-Kit, 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 1981-11-27.
- Submission: K813192
- Applicant / Sponsor: Syn-Kit, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1981-11-27
Classification & Regulation
This clearance is catalogued under FDA product code LBS and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.