Clearance Summary
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT received FDA 510(k) clearance under submission number K924496, sponsored by Drew Scientific , 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 1992-11-16.
- Submission: K924496
- Applicant / Sponsor: Drew Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7400
- Decision date: 1992-11-16
Classification & Regulation
This clearance is catalogued under FDA product code JPD and 21 CFR 864.7400, within the Hematology review panel as a Class II device.