Clearance Summary
CRIT-LINE HEMATOCRIT ALERT received FDA 510(k) clearance under submission number K950942, 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 1995-03-14.
- Submission: K950942
- Applicant / Sponsor: In-Line Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 1995-03-14
Classification & Regulation
This clearance is catalogued under FDA product code JPI and 21 CFR 864.6400, within the Hematology review panel as a Class II device.