Clearance Summary
DU PONT STERICELL CELL CULTURE SYSTEM received FDA 510(k) clearance under submission number K871324, sponsored by E.I. Dupont DE Nemours & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1987-04-14.
- Submission: K871324
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1987-04-14
Classification & Regulation
This clearance is catalogued under FDA product code KJA and 21 CFR 864.2240, within the Hematology review panel as a Class I device.