K-number	K192072
Device name	Tina-quant C-Reactive Protein IV
Applicant	Roche Diagnostics Operations (Rdo)
Product code	DCN
Device class	Class II
Decision date	Feb 21, 2020
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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Tina-quant C-Reactive Protein IV

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