Clearance Summary
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM received FDA 510(k) clearance under submission number K914188, sponsored by Ortho Diagnostic Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1992-08-26.
- Submission: K914188
- Applicant / Sponsor: Ortho Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1992-08-26
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.