Uibc for Discreet Random Access Analyzer

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K932871 ↗

FDA Product Code

CFM

Device Class

Class I

Regulation

21 CFR Part 862.1410

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase (Alt)/(Gpt)

  Class I

  FDA 510(k) K870086 Active Cleared 6 Mar 1987

• Aspartate Aminotransferase (Ast)/(Got)

  Class II

  FDA 510(k) K870077 Active Cleared 6 Mar 1987

• Direct Bilirubin for Manual or Automated Appli.

  Class II

  FDA 510(k) K892905 Active Cleared 19 Jun 1989

• Magnesium

  Class I

  FDA 510(k) K903341 Active Cleared 22 Aug 1990

• Uric Acid for Manual/Automated Applications

  Class I

  FDA 510(k) K895821 Active Cleared 5 Dec 1989

• Lactate Dehydrogenase (Ld) for Cont. Flow Instrum.

  Class II

  FDA 510(k) K860713 Active Cleared 24 Apr 1986

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