Clearance Summary
ACLAIMS-IS received FDA 510(k) clearance under submission number K912085, sponsored by W-Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1991-10-31.
- Submission: K912085
- Applicant / Sponsor: W-Technology
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 1991-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LNJ and 21 CFR 864.5260, within the Hematology review panel as a Class II device.