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510(k) K221007

cobas HCV by Roche Molecular Systems, Inc. — Product Code MZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2022
Date Received
April 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device Class
Class II
Regulation Number
866.3170
Review Panel
MI
Submission Type

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