Clearance Summary
TRIAGE D-DIMER TEST, MODEL 98100 received FDA 510(k) clearance under submission number K042890, sponsored by Biosite Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-11-29.
- Submission: K042890
- Applicant / Sponsor: Biosite Incorporated
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2004-11-29
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.