Name: Predicase
Price: 199 USD

K-number	K173798
Device name	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Applicant	Diasorin Molecular, LLC
Product code	PGI
Device class	Class II
Decision date	Mar 14, 2018
Decision	Substantially Equivalent
Regulation	866.3309

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

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