Clearance Summary
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 received FDA 510(k) clearance under submission number K050768, sponsored by Hamilton Thorne Biosciences. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-04-28.
- Submission: K050768
- Applicant / Sponsor: Hamilton Thorne Biosciences
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2005-04-28
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.