Digoxin Enzyme Immunoassay

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K963835 ↗

FDA Product Code

KXT

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• T4 Diagnostic Kit

  Class II

  FDA 510(k) K820251 Active Cleared 5 May 1982

• Serum Tox Calibrator

  Class II

  FDA 510(k) K961372 Active Cleared 1 May 1996

• Methadone Enzyme Immunoassay

  Class II

  FDA 510(k) K934667 Active Cleared 26 Jan 1994

• Cannabinoid Urine Controls

  Class I

  FDA 510(k) K932113 Active Cleared 29 Jun 1993

• Amphetamines Eia Assay Modification

  Class II

  FDA 510(k) K934891 Active Cleared 13 Jan 1994

• Thc Urine Calibrators

  Class II

  FDA 510(k) K923386 Active Cleared 14 Sep 1992

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