Total Galactose

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K894011 ↗

FDA Product Code

KQP

Device Class

Class II

Regulation

21 CFR Part 862.1315

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ast Aspartate Aminotransferase Reagent

  Class II

  FDA 510(k) K851994 Active Cleared 3 Jun 1985

• Alp(Alkaline)(Phosphatase) Reagent

  Class II

  FDA 510(k) K851998 Active Cleared 30 May 1985

• Clinalyzer Model Vx-1000

  Class I

  FDA 510(k) K851638 Active Cleared 13 May 1985

• Mg Reagent

  Class I

  FDA 510(k) K852005 Active Cleared 25 Jun 1985

• Rfa-300 Rapid Flow Analyzer W/Computer

  Class I

  FDA 510(k) K883020 Active Cleared 2 Sep 1988

• Alb Bcg Reagent

  Class II

  FDA 510(k) K852007 Active Cleared 30 May 1985

See all devices from Alpkem Corp. →