Clearance Summary
LUCINA-MELODI received FDA 510(k) clearance under submission number K112856, sponsored by Genadyne Biotechnologies, Inc.. 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 2012-05-10.
- Submission: K112856
- Applicant / Sponsor: Genadyne Biotechnologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2012-05-10
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.