Clearance Summary
BOUINS SOLUTION received FDA 510(k) clearance under submission number K833515, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1983-11-14.
- Submission: K833515
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1983-11-14
Classification & Regulation
This clearance is catalogued under FDA product code IGN and 21 CFR 864.4010, within the Pathology review panel as a Class I device.