K-number	K121991
Device name	ENTEROCOCCUS QUICKFISH BC
Applicant	Advandx, Inc.
Product code	OAH
Device class	Class I
Decision date	Jan 7, 2013
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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ENTEROCOCCUS QUICKFISH BC

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