Total Proteins

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850936 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Rapid As Latex

  Class I

  FDA 510(k) K862530 Active Cleared 21 Apr 1987

• Calcium

  Class II

  FDA 510(k) K850929 Active Cleared 10 Jun 1985

• Phosphorus

  Class I

  FDA 510(k) K850934 Active Cleared 25 Jun 1985

• Albumin

  Class II

  FDA 510(k) K850931 Active Cleared 26 Jun 1985

• Chloride (Mercuric Thiocyanate, Colorimetry)

  Class II

  FDA 510(k) K850935 Active Cleared 10 Jun 1985

• Creatinine

  Class II

  FDA 510(k) K850932 Active Cleared 25 Jun 1985

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