Clearance Summary
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) received FDA 510(k) clearance under submission number K013135, sponsored by Diagnostic Products Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-10-19.
- Submission: K013135
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2001-10-19
Classification & Regulation
This clearance is catalogued under FDA product code DHB and 21 CFR 866.5750, within the Immunology review panel as a Class II device.