Name: Predicase
Price: 199 USD

K-number	K060783
Device name	SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
Applicant	Trek Diagnostic Systems, Inc.
Product code	JWY
Device class	Class II
Decision date	May 16, 2006
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL

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