Clearance Summary
SAF FIXATIVE received FDA 510(k) clearance under submission number K831058, sponsored by American Micro Scan. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1983-06-08.
- Submission: K831058
- Applicant / Sponsor: American Micro Scan
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code LDW and 21 CFR 864.4010, within the Pathology review panel as a Class I device.