Clearance Summary
SICKLE-HEME A/S CONTROLS & A/A CONTROL received FDA 510(k) clearance under submission number K831871, 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 1983-07-28.
- Submission: K831871
- Applicant / Sponsor: Anco Medical Reagents & Assoc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7825
- Decision date: 1983-07-28
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.