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FDA 510(k)

Aptima® Chlamydia trachomatis Assay

K-Number: K230451 · 2023-11-16

ApplicantHologic, Inc.
Decision Date2023-11-16
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima® Chlamydia trachomatis 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 2023-11-16 under 510(k) number K230451. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima® Chlamydia trachomatis Assay?

Aptima® Chlamydia trachomatis Assay is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Hologic, Inc.. The 510(k) number is K230451.

When did Aptima® Chlamydia trachomatis Assay receive FDA 510(k) clearance?

Aptima® Chlamydia trachomatis Assay received FDA 510(k) clearance on 2023-11-16, under 510(k) number K230451.

Who is the listed applicant for Aptima® Chlamydia trachomatis 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® Chlamydia trachomatis Assay?

The FDA product code for Aptima® Chlamydia trachomatis Assay is MKZ.

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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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