Name: Predicase
Price: 199 USD

K-number	K040203
Device name	MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22
Applicant	Branan Medical Corp.
Product code	DKZ
Device class	Class II
Decision date	Mar 25, 2004
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22

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