Alanine Aminotransferase Test (Alt) Item # 65403

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K893752 ↗

FDA Product Code

CKA

Device Class

Class I

Regulation

21 CFR Part 862.1030

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

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• Systemate (Tm) Alanine Transferase (Alt)

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  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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