Clearance Summary
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS received FDA 510(k) clearance under submission number DEN050002, sponsored by Wako Chemicals USA, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-05-19.
- Submission: DEN050002
- Applicant / Sponsor: Wako Chemicals USA, Inc.
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6030
- Decision date: 2005-05-19
Classification & Regulation
This clearance is catalogued under FDA product code NSF and 21 CFR 866.6030, within the Immunology review panel as a Class II device.