Clearance Summary
CYTO-STAIN received FDA 510(k) clearance under submission number K830625, sponsored by Richard-Allan Medical Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-03-24.
- Submission: K830625
- Applicant / Sponsor: Richard-Allan Medical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1870
- Decision date: 1983-03-24
Classification & Regulation
This clearance is catalogued under FDA product code HJQ and 21 CFR 886.1870, within the Ophthalmic review panel as a Class I device.