Thyroid Stimulating Hormone (Tsh Irma) Ria Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K865071 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Luteinizing Hormone (Lh-Irma) Ria Kit

  Class I

  FDA 510(k) K864144 Active Cleared 24 Nov 1986

• Estradiol Kit by Ria

  Class I

  FDA 510(k) K820329 Active Cleared 4 Mar 1982

• Thyroid Stimulating Hormone (Htsh) Irma Neonatal

  Class II

  FDA 510(k) K883726 Active Cleared 15 Dec 1988

• Immuchem Covalent Coat Solid Phase Assay

  Class II

  FDA 510(k) K791663 Active Cleared 1 Oct 1979

• Immuchem Covalent-Coat Ria Kit

  Class II

  FDA 510(k) K830962 Active Cleared 4 May 1983

• Testosterone Kit

  Class I

  FDA 510(k) K801666 Active Cleared 27 Aug 1980

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