Stratus Digitoxin Fluorometric Enzyme Immunoassay

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K862067 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K840783 Active Cleared 4 Apr 1984

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  FDA 510(k) K831154 Active Cleared 16 May 1983

• Lactate Reagent

  Class I

  FDA 510(k) K840778 Active Cleared 13 Apr 1984

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  FDA 510(k) K841887 Active Cleared 22 Jun 1984

• Immu-Trace T3 Uptake (T3U) Reagents

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  FDA 510(k) K803044 Active Cleared 2 Jan 1981

• Uric Acid Reagent

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  FDA 510(k) K840781 Active Cleared 13 Apr 1984

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