Clearance Summary
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 received FDA 510(k) clearance under submission number K062025, sponsored by Corgenix, 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 2007-05-29.
- Submission: K062025
- Applicant / Sponsor: Corgenix, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 2007-05-29
Classification & Regulation
This clearance is catalogued under FDA product code OBW and 21 CFR 864.5700, within the Hematology review panel as a Class II device.