Name: Predicase
Price: 199 USD

K-number	K191729
Device name	Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Applicant	Roche Molecular Systems, Inc.
Product code	OCC
Device class	Class II
Decision date	Jul 24, 2019
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

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