Name: Predicase
Price: 199 USD

K-number	K091667
Device name	XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	OCC
Device class	Class II
Decision date	Jun 25, 2009
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116

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