Name: Predicase
Price: 199 USD

K-number	K983244
Device name	SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
Applicant	Trek Diagnostic Systems, Inc.
Product code	JTW
Device class	Class I
Decision date	Nov 30, 1998
Decision	Substantially Equivalent
Regulation	866.2900

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Source

View the full FDA submission: accessdata.fda.gov

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SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

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