Clearance Summary
CRYOPETTE received FDA 510(k) clearance under submission number K100596, sponsored by Mid-Atlantic Diagnostics, 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 2010-12-06.
- Submission: K100596
- Applicant / Sponsor: Mid-Atlantic Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2010-12-06
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.