Clearance Summary
SODIUM HYPOCHLORITE 3% received FDA 510(k) clearance under submission number K831620, sponsored by Omega Medical Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1983-07-28.
- Submission: K831620
- Applicant / Sponsor: Omega Medical Diagnostics
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1983-07-28
Classification & Regulation
This clearance is catalogued under FDA product code PPM and 21 CFR 864.4010, within the Pathology review panel as a Class I device.