Qms Vancomycin

• • Terminated Z-1102-2008 FDA Unclassified (pre-2012) ·initiated 20 Dec 2007

  False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

510(k) Number

K050419 ↗

FDA Product Code

LEH

Device Class

Class II

Regulation

21 CFR Part 862.3950

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K052826 Active Cleared 23 Dec 2005

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  Class II

  FDA 510(k) K874413 Active Cleared 5 Jan 1988

• Qms / Multigent Valproic Acid Reagent, Part #396075

  Class II

  FDA 510(k) K030405 Active Cleared 28 Apr 2003

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  Class I

  FDA 510(k) K924186 Active Cleared 23 Dec 1992

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  Class II

  FDA 510(k) K062966 Active Cleared 12 Jan 2007

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  Class II

  FDA 510(k) K913562 Active Cleared 30 Aug 1991

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