Clearance Summary
ULTRACLONE ECL-01-2100 CELL LINE received FDA 510(k) clearance under submission number K843578, sponsored by Earl-Clay Laboratories, 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 1984-10-31.
- Submission: K843578
- Applicant / Sponsor: Earl-Clay Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2280
- Decision date: 1984-10-31
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.