Clearance Summary
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY received FDA 510(k) clearance under submission number K905643, sponsored by Agen Biomedical , 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 1991-04-12.
- Submission: K905643
- Applicant / Sponsor: Agen Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 1991-04-12
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.