Clearance Summary
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) received FDA 510(k) clearance under submission number K242127, sponsored by Instrumentation Laboratory (IL) Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-08-16.
- Submission: K242127
- Applicant / Sponsor: Instrumentation Laboratory (IL) Co.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5400
- Decision date: 2024-08-16
Classification & Regulation
This clearance is catalogued under FDA product code GKP and 21 CFR 864.5400, within the Hematology review panel as a Class II device.