Catachem DiscretPak™ C402-0C

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Catachem DiscretPak™

Generic Name

Total bile acid IVD, kit, spectrophotometry

Model / Ref / Catalog

C402-0C

Primary DI / UDI-DI

00853618007011

510(k) Number

K062503 ↗

FDA Product Code

KWW

GMDN Term

Total bile acid IVD, kit, spectrophotometry

Device Class

Class II

Regulation Number

862.1177

GUDID distribution status

Not in Commercial Distribution

• 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

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