Clearance Summary
ULTRACLONE ECL-01-1400 CELL LINE received FDA 510(k) clearance under submission number K843864, 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 1984-10-17.
- Submission: K843864
- Applicant / Sponsor: Earl-Clay Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2220
- Decision date: 1984-10-17
Classification & Regulation
This clearance is catalogued under FDA product code KIT and 21 CFR 864.2220, within the Hematology review panel as a Class I device.