Sigma Diagnostics Thrombomax with Calcium

• • Terminated Z-0261-05 FDA Unclassified (pre-2012) ·initiated 27 Oct 2004

  Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

510(k) Number

K972796 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  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

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  Class II

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  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

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