Clearance Summary
SEPRACELL LYMPHOCYTE SEPARATION MEDIUM received FDA 510(k) clearance under submission number K860354, sponsored by Sepratech Corporation C/O Keller and Heckman. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1986-04-18.
- Submission: K860354
- Applicant / Sponsor: Sepratech Corporation C/O Keller and Heckman
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8500
- Decision date: 1986-04-18
Classification & Regulation
This clearance is catalogued under FDA product code JCF and 21 CFR 864.8500, within the Hematology review panel as a Class I device.