Clearance Summary
CRIT-SCAN II MONITOR received FDA 510(k) clearance under submission number K983551, sponsored by In-Line Diagnostics 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 1999-05-27.
- Submission: K983551
- Applicant / Sponsor: In-Line Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5600
- Decision date: 1999-05-27
Classification & Regulation
This clearance is catalogued under FDA product code GKF and 21 CFR 864.5600, within the Hematology review panel as a Class II device.