Name: Predicase
Price: 199 USD

K-number	K153474
Device name	Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
Applicant	Biochemical Diagnostics, Inc.
Product code	DIF
Device class	Class I
Decision date	Feb 23, 2016
Decision	Substantially Equivalent
Regulation	862.3280

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Source

View the full FDA submission: accessdata.fda.gov

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Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series

Everything you need for a 510(k) submission. Nothing you don't.