Clearance Summary
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS received FDA 510(k) clearance under submission number K951071, sponsored by Alko Diagnostic 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 1995-07-24.
- Submission: K951071
- Applicant / Sponsor: Alko Diagnostic Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8165
- Decision date: 1995-07-24
Classification & Regulation
This clearance is catalogued under FDA product code KRZ and 21 CFR 864.8165, within the Hematology review panel as a Class II device.