Luteinizing Hormone (Lh-Irma) Ria Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864144 ↗

FDA Product Code

CEP

Device Class

Class I

Regulation

21 CFR Part 862.1485

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K820329 Active Cleared 4 Mar 1982

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  Class II

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• Immuchem Covalent Coat Solid Phase Assay

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  Class I

  FDA 510(k) K801666 Active Cleared 27 Aug 1980

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