Biocheck Total T4 Enzyme Immunoassay Test Kit, Model Bc-1007

• • Ongoing Z-0310-2022 FDA Class II ·initiated 18 Oct 2021

  Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

• • Terminated Z-0214-2022 FDA Class II ·initiated 14 Oct 2021

  Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

510(k) Number

K991432 ↗

FDA Product Code

KLI

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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