Clearance Summary
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY received FDA 510(k) clearance under submission number K850412, 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 1985-05-08.
- Submission: K850412
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7060
- Decision date: 1985-05-08
Classification & Regulation
This clearance is catalogued under FDA product code JBQ and 21 CFR 864.7060, within the Hematology review panel as a Class II device.