(125I) Testosterone Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791999 ↗

FDA Product Code

CDZ

Device Class

Class I

Regulation

21 CFR Part 862.1680

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Rsl (125I) Aldosterone Kit

  Class II

  FDA 510(k) K862204 Active Cleared 25 Sep 1986

• Total Estrogens Kit by Ria

  Class I

  FDA 510(k) K791651 Active Cleared 27 Sep 1979

• Rsl (125 L) Progesterone Kit

  Class I

  FDA 510(k) K800126 Active Cleared 13 Feb 1980

• Estradiol Kit by Ria

  Class I

  FDA 510(k) K791652 Active Cleared 27 Sep 1979

• Hatch Kit

  Class II

  FDA 510(k) K831855 Active Cleared 28 Jul 1983

• Serum 11-Desoxycortisol I As Tracer

  Class I

  FDA 510(k) K791740 Active Cleared 27 Sep 1979

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