Clearance Summary
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 received FDA 510(k) clearance under submission number K013545, sponsored by Sigma Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2001-11-15.
- Submission: K013545
- Applicant / Sponsor: Sigma Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2001-11-15
Classification & Regulation
This clearance is catalogued under FDA product code DAP and 21 CFR 864.7320, within the Hematology review panel as a Class II device.