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510(k) K221007

Device
Cobas HCV
Applicant
Roche Molecular Systems, Inc.
510(k) number
K221007
Product code
MZP  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-04
Date received
2022-04-05
Regulation
866.3170
Classification name
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ashley Malich
Address
4300 Hacienda Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252484cobas HCVRoche Molecular Systems, Inc.2025-11-03
K252102Alinity m HCVAbbott Molecular, Inc.2025-09-25
K233352Aptima HCV Quant Dx AssayHologic, Inc.2024-07-24

Legacy Summary#

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FDA Review#

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