Clearance Summary
HUMAN NEWBORN FORESKIN CELL CULTURE received FDA 510(k) clearance under submission number K943887, sponsored by Neogenex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1994-11-28.
- Submission: K943887
- Applicant / Sponsor: Neogenex
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2280
- Decision date: 1994-11-28
Classification & Regulation
This clearance is catalogued under FDA product code KIR and 21 CFR 864.2280, within the Hematology review panel as a Class I device.