Name: Predicase
Price: 199 USD

K-number	K030113
Device name	MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
Applicant	Branan Medical Corp.
Product code	DJG
Device class	Class II
Decision date	Jul 2, 2003
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23

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