Clearance Summary
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM received FDA 510(k) clearance under submission number K913967, sponsored by Doxtech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1991-10-18.
- Submission: K913967
- Applicant / Sponsor: Doxtech, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3250
- Decision date: 1991-10-18
Classification & Regulation
This clearance is catalogued under FDA product code KDW and 21 CFR 864.3250, within the Pathology review panel as a Class I device.