Clearance Summary
SUDAN IV HERXHEIMER received FDA 510(k) clearance under submission number K842916, sponsored by E K Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-09-11.
- Submission: K842916
- Applicant / Sponsor: E K Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1984-09-11
Classification & Regulation
This clearance is catalogued under FDA product code KKK and 21 CFR 864.1850, within the Hematology review panel as a Class I device.