Clearance Summary
SICKLE CELL REAGENT SET received FDA 510(k) clearance under submission number K811828, 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 1981-08-12.
- Submission: K811828
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7825
- Decision date: 1981-08-12
Classification & Regulation
This clearance is catalogued under FDA product code GHM and 21 CFR 864.7825, within the Hematology review panel as a Class II device.