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FDA 510(k)

cobas HCV

K-Number: K221007 · 2022-11-04

ApplicantRoche Molecular Systems, Inc.
Decision Date2022-11-04
Product CodeMZP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas HCV is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2022-11-04 under approval number K221007. The device is classified under product code MZP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas HCV?

cobas HCV is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K221007.

When was cobas HCV approved by the FDA?

cobas HCV received FDA 510(k) clearance on 2022-11-04, under approval number K221007.

What company makes cobas HCV?

cobas HCV is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas HCV?

The FDA product code for cobas HCV is MZP.

Other Devices by Roche Molecular Systems, Inc.

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Related Devices (Code: MZP)

K233352Aptima HCV Quant Dx AssayHologic, Inc. K252484cobas HCVRoche Molecular Systems, Inc. K252102Alinity m HCVAbbott Molecular, Inc. PMA P100017Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusAbbott Molecular, Inc. PMA P150015Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc. PMA P060030Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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