Name: Predicase
Price: 199 USD

K-number	K002337
Device name	BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
Applicant	Branan Medical Corporation
Product code	DIS
Device class	Class II
Decision date	Nov 22, 2000
Decision	Substantially Equivalent
Regulation	862.3150

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Source

View the full FDA submission: accessdata.fda.gov

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BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST

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