Name: Predicase
Price: 199 USD

K-number	K992207
Device name	QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
Applicant	Syntron Bioresearch, Inc.
Product code	DIO
Device class	Class II
Decision date	Jul 22, 1999
Decision	Substantially Equivalent
Regulation	862.3250

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Source

View the full FDA submission: accessdata.fda.gov

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QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM

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