Name: Predicase
Price: 199 USD

K-number	K150039
Device name	MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	LTT
Device class	Class II
Decision date	Jul 2, 2015
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 Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)

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