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Medicine / Drug test / Oxycodone / Morphine / Methadone / MDMA / Cocaine / Presumptive and confirmatory tests / Amphetamine / Chemistry / Euphoriants / Neurochemistry


510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091588
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Document Date: 2009-10-05 08:53:58

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File Size: 129,66 KB

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Company

UCP Biosciences Inc. / /

IndustryTerm

food interference / cleared prescription devices / care drug testing product / gas chromatography/mass spectrometry / predicate device / lateral flow immunochromatographic technology / transportation bag / /

Position

Amphetamine Barbiturates Benzodiazepines Cocaine Marijuana Methadone Methamphetamine MDMA Calibrator / /

Product

Tricyclic Antidepressant / /

ProvinceOrState

Texas / California / Pennsylvania / /

Technology

lateral flow immunochromatographic technology / gas chromatography / Drug Screening / /

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