Name: Predicase
Price: 199 USD

K-number	K071511
Device name	PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
Applicant	Focus Diagnostics, Inc.
Product code	MXJ
Device class	Class II
Decision date	Oct 5, 2007
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G

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