Clearance Summary
ZILOS-TK received FDA 510(k) clearance under submission number K063636, sponsored by Hamilton Thorne Biosciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2007-04-24.
- Submission: K063636
- Applicant / Sponsor: Hamilton Thorne Biosciences
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2007-04-24
Classification & Regulation
This clearance is catalogued under FDA product code MRX and 21 CFR 884.6200, within the Obstetrics/Gynecology review panel as a Class II device.