Clearance Summary
EDL ONE-STAGE PROTHROMBIN TIME REAGENT received FDA 510(k) clearance under submission number K891370, 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: K891370
- Applicant / Sponsor: Elite Diagnostic , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 1989-04-21
Classification & Regulation
This clearance is catalogued under FDA product code GJS and 21 CFR 864.7750, within the Hematology review panel as a Class II device.