Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and Saliva

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K033786 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva

  Class I

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• Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum

  Class I

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