Clearance Summary
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 received FDA 510(k) clearance under submission number K100716, sponsored by Aalto 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 2011-06-23.
- Submission: K100716
- Applicant / Sponsor: Aalto Scientific, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2011-06-23
Classification & Regulation
This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.