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510(k) K233352

Device
Aptima HCV Quant Dx Assay
Applicant
Hologic, Inc.
510(k) number
K233352
Product code
MZP
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-24
Date received
2023-09-29
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
Howard Liu
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

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
K221007cobas HCVRoche Molecular Systems, Inc.2022-11-04