Clearance Summary
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS received FDA 510(k) clearance under submission number K962864, 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 1996-12-18.
- Submission: K962864
- Applicant / Sponsor: Alko Diagnostic Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8165
- Decision date: 1996-12-18
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.