Name: Predicase
Price: 199 USD

K-number	K231306
Device name	cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Applicant	Roche Molecular Systems, Inc.
Product code	QQX
Device class	Class II
Decision date	Jun 1, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

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