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510(k) K252484

Device
cobas HCV
Applicant
Roche Molecular Systems, Inc.
510(k) number
K252484
Product code
MZP
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-03
Date received
2025-08-07
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
N

Applicant Contact#

Contact
Nghia Luu
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
K252102Alinity m HCVAbbott Molecular, Inc.2025-09-25
K233352Aptima HCV Quant Dx AssayHologic, Inc.2024-07-24
K221007cobas HCVRoche Molecular Systems, Inc.2022-11-04