Clearance Summary
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit received FDA 510(k) clearance under submission number K162705, sponsored by Maine Standards Company, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-01-05.
- Submission: K162705
- Applicant / Sponsor: Maine Standards Company, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2017-01-05
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.