Name: Predicase
Price: 199 USD

K-number	K223478
Device name	VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
Applicant	bioMerieux, Inc.
Product code	LON
Device class	Class II
Decision date	Feb 16, 2023
Decision	Substantially Equivalent
Regulation	866.1645

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Source

View the full FDA submission: accessdata.fda.gov

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VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin

Everything you need for a 510(k) submission. Nothing you don't.