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510(k) K252484

cobas HCV by Roche Molecular Systems, Inc. — Product Code MZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2025
Date Received
August 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device Class
Class II
Regulation Number
866.3170
Review Panel
MI
Submission Type

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  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
  • K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (February 11, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
  • K240197 — cobas® liat CT/NG/MG nucleic acid test (January 16, 2025)

Other clearances for product code MZP

  • K252102 — Alinity m HCV (September 25, 2025)
  • K233352 — Aptima HCV Quant Dx Assay (July 24, 2024)
  • K221007 — cobas HCV (November 4, 2022)