Clearance Summary
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 received FDA 510(k) clearance under submission number K983263, sponsored by Diagnostic Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-12-07.
- Submission: K983263
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1998-12-07
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.