Immulite Hcg, Model LKCG1, LCCG5, Immulite 2000 Hcg, Model L2KCG2, L2KCG6

• • Ongoing Z-1015-2022 FDA Class II ·initiated 22 Feb 2022

  Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

510(k) Number

K990222 ↗

FDA Product Code

DHA

Models / Variants

LKCG1

LCCG5

Immulite 2000 Hcg

Model L2KCG2

L2KCG6

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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