Clearance Summary
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL received FDA 510(k) clearance under submission number K070453, sponsored by Olympus Life & Material Science Europa GmbH (Irish. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-06-11.
- Submission: K070453
- Applicant / Sponsor: Olympus Life & Material Science Europa GmbH (Irish
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2007-06-11
Classification & Regulation
This clearance is catalogued under FDA product code GHH and 21 CFR 864.7320, within the Hematology review panel as a Class II device.