Immulite 2000 Anti-Tg Ab, Model L2KTG2, L2KTG6

• • Ongoing Z-1886-2024 FDA Class II ·initiated 23 Apr 2024

  The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

• • Ongoing Z-1887-2024 FDA Class II ·initiated 23 Apr 2024

  The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

510(k) Number

K991094 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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