Emit-Amd Amikacin Control

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K820439 ↗

FDA Product Code

LAS

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K810466 Active Cleared 6 Mar 1981

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  Class I

  FDA 510(k) K921747 Active Cleared 1 Oct 1992

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  Class I

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• Modif. of Emit Cad Disopyramide Assay

  Class II

  FDA 510(k) K833623 Active Cleared 8 Dec 1983

• Emit Auto Cortisol Assay

  Class II

  FDA 510(k) K800245 Active Cleared 3 Mar 1980

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