Clearance Summary
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 received FDA 510(k) clearance under submission number K993332, sponsored by Gradipore , 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 2000-02-16.
- Submission: K993332
- Applicant / Sponsor: Gradipore , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2000-02-16
Classification & Regulation
This clearance is catalogued under FDA product code GGC and 21 CFR 864.5425, within the Hematology review panel as a Class II device.