Somas Human Spinal Fluid Control

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

510(k) Number

K840974 ↗

FDA Product Code

DFI

Device Class

Class I

Regulation

21 CFR Part 866.5860

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Total Bilirubin Reagent

  Class II

  FDA 510(k) K840486 Active Cleared 25 Apr 1984

• Somas Coomasie Blue Total Protein Assay

  Class II

  FDA 510(k) K842134 Active Cleared 6 Jul 1984

• Somas Liquid Urine Control

  Class I

  FDA 510(k) K862179 Active Cleared 1 Jul 1986

• Total Iron Uibc/Tibc Assay

  Class I

  FDA 510(k) K840485 Active Cleared 12 Mar 1984

• Somas Chloride Assay Kit

  Not classified

  FDA 510(k) K833787 Active Cleared 11 Jan 1984