FDA 510(k) Applications Submitted by MICHELLE NEFF

FDA 510(k) Number Submission Date Device Name Applicant
K093867 01/05/2010 ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A Roche Diagnostics
K093989 12/24/2009 ORAL FLUID PHENCYCLIDINE Roche Diagnostics
K083764 12/18/2008 AMPHETAMINES II ROCHE DIAGNOSTICS CORP.
K090939 04/03/2009 ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 Roche Diagnostics
K093664 11/27/2009 AMPHETAMINES II ASSAY ROCHE DIAGNOSTICS CORP.
K110446 02/16/2011 ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID Roche Diagnostics
K101160 04/26/2010 ROCHE ORAL FLUID COCAINE Roche Diagnostics
K093884 12/18/2009 ROCHE FLUDI METHAMPHETAMINE Roche Diagnostics


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