Du Pont Dimension(R) Phenytoin (Ptn) Method

• • Terminated Z-0148-2015 FDA Class II ·initiated 24 Sep 2014

  Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.

510(k) Number

K911056 ↗

FDA Product Code

DIP

Device Class

Class II

Regulation

21 CFR Part 862.3350

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K771802 Active Cleared 25 Oct 1977

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  Class II

  FDA 510(k) K850058 Active Cleared 18 Jan 1985

• Du Pont Xenolite(Tm) Radiation Protection Apparel

  Class I

  FDA 510(k) K896511 Active Cleared 22 Dec 1989

• Aca Carbon Dioxide Calibrator

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  FDA 510(k) K771801 Active Cleared 25 Oct 1977

• Du Pont Aca Plus Immunoasssay System Hcg Calibrato

  Class II

  FDA 510(k) K922696 Active Cleared 12 Aug 1992

• Du Pont Analyst Analytical Test Rotor:CHEM-14, Cali

  Class II

  FDA 510(k) K901017 Active Cleared 15 May 1990

See all devices from E.I. Dupont DE Nemours & Co., Inc. →