Clearance Summary
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY received FDA 510(k) clearance under submission number K850410, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1985-05-08.
- Submission: K850410
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5715
- Decision date: 1985-05-08
Classification & Regulation
This clearance is catalogued under FDA product code DDX and 21 CFR 866.5715, within the Immunology review panel as a Class I device.