Immulite Digoxin

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K914833 ↗

FDA Product Code

DPO

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

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 T3

  Class II

  FDA 510(k) K905214 Active Cleared 1 Feb 1991

• Immulite(Tm) Total T4

  Class II

  FDA 510(k) K910261 Active Cleared 16 Apr 1991

• Immulite(R) Fsh

  Class I

  FDA 510(k) K921704 Active Cleared 9 Jun 1992

See all devices from Cirrus Diagnostics, Inc. →