K-number	K180936
Device name	ETEST Telavancin (TLA) (0.002-32 ug/mL)
Applicant	Biomerieux S.A.
Product code	JWY
Device class	Class II
Decision date	Jul 3, 2018
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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ETEST Telavancin (TLA) (0.002-32 ug/mL)

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