K-number	K252484
Device name	cobas HCV
Applicant	Roche Molecular Systems, Inc.
Product code	MZP
Device class	Class II
Decision date	Nov 3, 2025
Decision	Substantially Equivalent
Regulation	866.3170

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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cobas HCV

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