Clearance Summary
CHOLESTEROL REAGENT SUBSTRATE SET received FDA 510(k) clearance under submission number K781970, sponsored by Corning Medical & Scientific. 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 1979-01-03.
- Submission: K781970
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1979-01-03
Classification & Regulation
This clearance is catalogued under FDA product code JHO and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.