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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) 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. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K221007.

When did cobas HCV receive FDA 510(k) clearance?

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

Who is the listed applicant for cobas HCV?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas HCV?

The FDA product code for cobas HCV is MZP.

Other records listing Roche Molecular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260021cobas® BV/CVK260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection system

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Related Devices (Code: MZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252484cobas HCVRoche Molecular Systems, Inc.K252102Alinity m HCVAbbott Molecular, Inc.K233352Aptima HCV Quant Dx AssayHologic, Inc.PMA P060030Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.PMA P150015Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.PMA P190025Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusAbbott Molecular, 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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