Clearance Summary
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 received FDA 510(k) clearance under submission number K991096, 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 1999-05-13.
- Submission: K991096
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 1999-05-13
Classification & Regulation
This clearance is catalogued under FDA product code JZO and 21 CFR 866.5870, within the Immunology review panel as a Class II device.