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FDA 510(k)

Aptima CV/TV Assay

K-Number: K190472 · 2019-05-16

ApplicantHologic, Inc.
Decision Date2019-05-16
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima CV/TV 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 2019-05-16 under 510(k) number K190472. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima CV/TV Assay?

Aptima CV/TV Assay is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Hologic, Inc.. The 510(k) number is K190472.

When did Aptima CV/TV Assay receive FDA 510(k) clearance?

Aptima CV/TV Assay received FDA 510(k) clearance on 2019-05-16, under 510(k) number K190472.

Who is the listed applicant for Aptima CV/TV 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 CV/TV Assay?

The FDA product code for Aptima CV/TV Assay is PQA.

Related Clinical Trials

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Related Devices (Code: PQA)

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.

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD Vaginal PanelBecton, Dickinson and CompanyK243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheidK223653BD Vaginal PanelBecton, Dickinson and CompanyK221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

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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