K-number	K232395
Device name	ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
Applicant	Biomérieux
Product code	JWY
Device class	Class II
Decision date	Oct 5, 2023
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

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