Clearance Summary
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument received FDA 510(k) clearance under submission number K163274, sponsored by Aggredyne, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-04-05.
- Submission: K163274
- Applicant / Sponsor: Aggredyne, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 2017-04-05
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.