Clearance Summary
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM received FDA 510(k) clearance under submission number K991395, sponsored by Advanced Reproductive Technologies. 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 2000-02-15.
- Submission: K991395
- Applicant / Sponsor: Advanced Reproductive Technologies
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2000-02-15
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.