Clearance Summary
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 received FDA 510(k) clearance under submission number K013566, sponsored by Diagnostic Products Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-11-20.
- Submission: K013566
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 2001-11-20
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.