Name: Predicase
Price: 199 USD

K-number	K190109
Device name	MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
Applicant	Beckman Coulter, Inc.
Product code	JWY
Device class	Class II
Decision date	Apr 18, 2019
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

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