Clearance Summary
CENTIDISC received FDA 510(k) clearance under submission number K813524, sponsored by Bel-Art Products. 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 1981-12-31.
- Submission: K813524
- Applicant / Sponsor: Bel-Art Products
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1981-12-31
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.