Name: Predicase
Price: 199 USD

K-number	K181975
Device name	Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
Applicant	Oxoid Limited (Part of Thermo Fisher Scientific)
Product code	JTN
Device class	Class II
Decision date	Sep 27, 2018
Decision	Substantially Equivalent
Regulation	866.1620

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Source

View the full FDA submission: accessdata.fda.gov

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Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

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