Clearance Summary
Glocyte Automated Cell Counter System received FDA 510(k) clearance under submission number K152776, sponsored by Advanced Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2016-05-27.
- Submission: K152776
- Applicant / Sponsor: Advanced Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 2016-05-27
Classification & Regulation
This clearance is catalogued under FDA product code GKL and 21 CFR 864.5200, within the Hematology review panel as a Class II device.