Clearance Summary
MANUAL BLOOD CELL COUNTING DEVICE received FDA 510(k) clearance under submission number K841026, sponsored by Instrumentation Laboratory CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-04-04.
- Submission: K841026
- Applicant / Sponsor: Instrumentation Laboratory CO
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6160
- Decision date: 1984-04-04
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.