K-number	K183031
Device name	ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
Applicant	Biomerieux S.A.
Product code	JWY
Device class	Class II
Decision date	Jan 11, 2019
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

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