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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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2023-11-16 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K230451.

When was Aptima® Chlamydia trachomatis Assay approved by the FDA?

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

What company makes Aptima® Chlamydia trachomatis Assay?

Aptima® Chlamydia trachomatis Assay is manufactured by Hologic, Inc..

What is the FDA product code for Aptima® Chlamydia trachomatis Assay?

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

Related Clinical Trials

NCT07596316 Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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