Clearance Summary
LUPO-TEST REAGENT received FDA 510(k) clearance under submission number K903037, 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 1990-12-17.
- Submission: K903037
- Applicant / Sponsor: Gradipore , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 1990-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GIR and 21 CFR 864.8950, within the Hematology review panel as a Class I device.