Clearance Summary
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) received FDA 510(k) clearance under submission number K953875, sponsored by In-Line Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1996-07-23.
- Submission: K953875
- Applicant / Sponsor: In-Line Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1996-07-23
Classification & Regulation
This clearance is catalogued under FDA product code MQS and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.