Clearance Summary
SYVA SOLID PHASE COLUMNS SYSTEM II received FDA 510(k) clearance under submission number K861392, sponsored by Syva Co.. 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 1986-06-13.
- Submission: K861392
- Applicant / Sponsor: Syva Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1986-06-13
Classification & Regulation
This clearance is catalogued under FDA product code KZR and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.