Ck(Optimized) Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854501 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Total T4 FPIA Reagent Set/Calibrator #T-1039, T-116

  Class II

  FDA 510(k) K932980 Active Cleared 18 Oct 1993

• Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

  Class II

  FDA 510(k) K001403 Active Cleared 10 Aug 2000

• Albumin (Bcg) Reagent

  Class II

  FDA 510(k) K861467 Active Cleared 23 May 1986

• Bile Acids Calibrator

  Class II

  FDA 510(k) K872451 Active Cleared 21 Aug 1987

• Aspartate Aminotransferase Procedure No.. 58-Uv

  Class II

  FDA 510(k) K954839 Active Cleared 5 Jan 1996

• Ethanol Controls, Urine, Levels 1, II, and III

  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

See all devices from Sigma Diagnostics, Inc. →