Clearance Summary
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) received FDA 510(k) clearance under submission number K160276, sponsored by Instrumentation Laboratory 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 2016-03-03.
- Submission: K160276
- Applicant / Sponsor: Instrumentation Laboratory CO
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5400
- Decision date: 2016-03-03
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.