Clearance Summary
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM received FDA 510(k) clearance under submission number K992851, sponsored by Roche 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 2000-01-14.
- Submission: K992851
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7140
- Decision date: 2000-01-14
Classification & Regulation
This clearance is catalogued under FDA product code JBP and 21 CFR 864.7140, within the Hematology review panel as a Class II device.