Clearance Summary
EDL ABNORMAL COAGULATION CONTROL received FDA 510(k) clearance under submission number K891175, 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 1989-04-10.
- Submission: K891175
- Applicant / Sponsor: Elite Diagnostic , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1989-04-10
Classification & Regulation
This clearance is catalogued under FDA product code GGL and 21 CFR 864.8625, within the Hematology review panel as a Class II device.