Clearance Summary
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT received FDA 510(k) clearance under submission number K071934, sponsored by Biomet Manufacturing Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2007-10-11.
- Submission: K071934
- Applicant / Sponsor: Biomet Manufacturing Corp
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2007-10-11
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.