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FDA 510(k)

Aptima BV Assay; Aptima CV/TV Assay

K-Number: K243345 · 2024-11-25

ApplicantHologic, Inc.
Decision Date2024-11-25
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima BV Assay; 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 2024-11-25 under 510(k) number K243345. 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 BV Assay; Aptima CV/TV Assay?

Aptima BV Assay; Aptima CV/TV Assay is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Hologic, Inc.. The 510(k) number is K243345.

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

Aptima BV Assay; Aptima CV/TV Assay received FDA 510(k) clearance on 2024-11-25, under 510(k) number K243345.

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

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

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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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