Clearance Summary
DIGITAL-9 KEY LEUCOCYTE COUNTER received FDA 510(k) clearance under submission number K854685, sponsored by Future Impex Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1986-04-04.
- Submission: K854685
- Applicant / Sponsor: Future Impex Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6160
- Decision date: 1986-04-04
Classification & Regulation
This clearance is catalogued under FDA product code GKM and 21 CFR 864.6160, within the Hematology review panel as a Class I device.