Name: Predicase
Price: 199 USD

K-number	K004034
Device name	MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
Applicant	Branan Medical Corp.
Product code	DKZ
Device class	Class II
Decision date	Mar 8, 2001
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12

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