K-number	K192050
Device name	ETEST Eravacycline (ERV) (0.002 32 µg/mL)
Applicant	Biomerieux S.A.
Product code	JWY
Device class	Class II
Decision date	Sep 27, 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 Eravacycline (ERV) (0.002  32 µg/mL)

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ETEST Eravacycline (ERV) (0.002 32 µg/mL)