Easy-Test Emit Gentamicin (Gent) Item No. 16640

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K871329 ↗

FDA Product Code

LCD

Device Class

Class II

Regulation

21 CFR Part 862.3450

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

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  Class II

  FDA 510(k) K864926 Active Cleared 7 Jan 1987

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  Class II

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• Systemate (Tm) Alanine Transferase (Alt)

  Class II

  FDA 510(k) K863094 Active Cleared 29 Aug 1986

• Systemate Ldh, 67210

  Class II

  FDA 510(k) K843269 Active Cleared 13 Sep 1984

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