Clearance Summary
IRON STAIN PROCEDURE HT20 received FDA 510(k) clearance under submission number K833388, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-10-31.
- Submission: K833388
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1983-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LED and 21 CFR 864.1850, within the Hematology review panel as a Class I device.