Name: Predicase
Price: 199 USD

K-number	K172255
Device name	MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
Applicant	Beckman Coulter, Inc.
Product code	LTT
Device class	Class II
Decision date	Dec 1, 2017
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 Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

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