Name: Predicase
Price: 199 USD

K-number	K082508
Device name	FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
Applicant	Branan Medical Corporation
Product code	DJG
Device class	Class II
Decision date	Nov 21, 2008
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD

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