Creatinine for Manual or Automated Applications

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K894389 ↗

FDA Product Code

GGX

Device Class

Class I

Regulation

21 CFR Part 864.6160

Advisory Committee

Hematology

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

• Uibc for Discreet Random Access Analyzer

  Class I

  FDA 510(k) K932871 Active Cleared 8 Sep 1993

• 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

See all devices from Catachem, Inc. →