Immulite (Tm) Total T3

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K905214 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Immulite (Tm) Automated Immunoassay Analyzer

  Class I

  FDA 510(k) K905215 Active Cleared 11 Jan 1991

• Immulite(Tm) T-Uptake

  Class II

  FDA 510(k) K910677 Active Cleared 29 Apr 1991

• Crp Lipid Reagent Test Pack

  Class I

  FDA 510(k) K905648 Active Cleared 6 Mar 1991

• Immulite(Tm) Total T4

  Class II

  FDA 510(k) K910261 Active Cleared 16 Apr 1991

• Immulite Digoxin

  Class II

  FDA 510(k) K914833 Active Cleared 22 Nov 1991

• Immulite(R) Fsh

  Class I

  FDA 510(k) K921704 Active Cleared 9 Jun 1992

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