K-number	K191953
Device name	ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
Applicant	Biomerieux S.A.
Product code	JWY
Device class	Class II
Decision date	Aug 22, 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 Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

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