Raichem(Tm) Spia(Tm) Microalbulmin Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K903123 ↗

FDA Product Code

JIQ

Device Class

Class I

Regulation

21 CFR Part 862.1645

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Total Protein Reagent Biuret

  Class II

  FDA 510(k) K841466 Active Cleared 16 May 1984

• Raichem Creatine Kinase Reagent, Optimized UV

  Class II

  FDA 510(k) K905084 Active Cleared 20 Dec 1990

• Raichem Acid Phosphatase Reagent

  Class II

  FDA 510(k) K831834 Active Cleared 26 Aug 1983

• Raichem Spia Apo B Reagents

  Class II

  FDA 510(k) K872080 Active Cleared 15 Jun 1987

• Raichem(Tm) Spia(Tm) Igm Reagents

  Class II

  FDA 510(k) K894417 Active Cleared 2 Aug 1989

• Uric Acid Reagent-Enzymatic-Color-520 Nm

  Class I

  FDA 510(k) K812641 Active Cleared 2 Oct 1981

See all devices from Reagents Applications, Inc. →