Clearance Summary
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L received FDA 510(k) clearance under submission number K991396, sponsored by Sage Biopharma. 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: K991396
- Applicant / Sponsor: Sage Biopharma
- 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.