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FDA 510(k) Applications Submitted by MICHELLE LEE 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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