Clearance Summary
STERILE BLOOD COLLECTION SET received FDA 510(k) clearance under submission number K780657, sponsored by Suru Chemicals & Pharmaceuticals, Ltd.. 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 1978-07-19.
- Submission: K780657
- Applicant / Sponsor: Suru Chemicals & Pharmaceuticals, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1978-07-19
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.