Clearance Summary
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL received FDA 510(k) clearance under submission number K833352, 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 1983-11-03.
- Submission: K833352
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7340
- Decision date: 1983-11-03
Classification & Regulation
This clearance is catalogued under FDA product code GIL and 21 CFR 864.7340, within the Hematology review panel as a Class II device.