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FDA 510(k)

Aptima HCV Quant Dx Assay

K-Number: K233352 · 2024-07-24

ApplicantHologic, Inc.
Decision Date2024-07-24
Product CodeMZP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima HCV Quant Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K233352. 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 Aptima HCV Quant Dx Assay?

Aptima HCV Quant Dx Assay is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Hologic, Inc.. The 510(k) number is K233352.

When did Aptima HCV Quant Dx Assay receive FDA 510(k) clearance?

Aptima HCV Quant Dx Assay received FDA 510(k) clearance on 2024-07-24, under 510(k) number K233352.

Who is the listed applicant for Aptima HCV Quant Dx Assay?

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

What is the FDA product code for Aptima HCV Quant Dx Assay?

The FDA product code for Aptima HCV Quant Dx Assay is MZP.

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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.K221007cobas HCVRoche Molecular Systems, 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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