Clearance Summary
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME received FDA 510(k) clearance under submission number K890859, sponsored by Elite Diagnostic , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1989-04-21.
- Submission: K890859
- Applicant / Sponsor: Elite Diagnostic , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 1989-04-21
Classification & Regulation
This clearance is catalogued under FDA product code GFO and 21 CFR 864.7925, within the Hematology review panel as a Class II device.