Clearance Summary
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 received FDA 510(k) clearance under submission number K100616, sponsored by Life Technologies Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-05-20.
- Submission: K100616
- Applicant / Sponsor: Life Technologies Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5885
- Decision date: 2010-05-20
Classification & Regulation
This clearance is catalogued under FDA product code NDS and 21 CFR 876.5885, within the Gastroenterology, Urology review panel as a Class II device.