Clearance Summary
MICROFILTRATION SET MF10 received FDA 510(k) clearance under submission number K770253, sponsored by Biotest-Serum-Institut. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1977-04-05.
- Submission: K770253
- Applicant / Sponsor: Biotest-Serum-Institut
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1977-04-05
Classification & Regulation
This clearance is catalogued under FDA product code CAK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.