Immulite Intact Pth, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact Pth, Model L2KPP (200 Tests), L2K6

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K011505 ↗

FDA Product Code

CEW

Models / Variants

LKPP1 (100 Tests)

LKPP5 (500 Tests)

Immulite 2000 Intact Pth

Model L2KPP (200 Tests)

L2K6

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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