Clearance Summary
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT received FDA 510(k) clearance under submission number K002948, sponsored by Kamiya Biomedical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2001-05-18.
- Submission: K002948
- Applicant / Sponsor: Kamiya Biomedical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2001-05-18
Classification & Regulation
This clearance is catalogued under FDA product code DAP and 21 CFR 864.7320, within the Hematology review panel as a Class II device.