Name: Predicase
Price: 199 USD

K-number	K142293
Device name	Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
Applicant	Biophor Diagnostics, Inc.
Product code	LAF
Device class	Class II
Decision date	Sep 18, 2015
Decision	Substantially Equivalent
Regulation	862.3610

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Source

View the full FDA submission: accessdata.fda.gov

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Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

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