Clearance Summary
GENERAL DIAGNOSTICS COAG-A-MATE XC received FDA 510(k) clearance under submission number K852843, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-08-13.
- Submission: K852843
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1985-08-13
Classification & Regulation
This clearance is catalogued under FDA product code KQC and 21 CFR 864.1850, within the Hematology review panel as a Class I device.