Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and Libasys

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

De Novo Number

DEN050002 ↗

FDA Product Code

NSF

Device Class

Class II

Regulation

21 CFR Part 866.6030

Advisory Committee

Immunology

FDA Decision

DENG De Novo granted

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →