Clearance Summary
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH received FDA 510(k) clearance under submission number K842440, sponsored by Anco Medical Reagents & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-07-27.
- Submission: K842440
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1984-07-27
Classification & Regulation
This clearance is catalogued under FDA product code JPK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.