Name: Predicase
Price: 199 USD

K-number	K141748
Device name	RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
Applicant	Biophor Diagnostics, Inc.
Product code	DKZ
Device class	Class II
Decision date	May 20, 2015
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET

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