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FDA 510(k)

Aptima Neisseria gonorrhoeae Assay

K-Number: K231329 · 2024-01-26

ApplicantHologic, Inc.
Decision Date2024-01-26
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima Neisseria gonorrhoeae 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 2024-01-26 under 510(k) number K231329. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima Neisseria gonorrhoeae Assay?

Aptima Neisseria gonorrhoeae Assay is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Hologic, Inc.. The 510(k) number is K231329.

When did Aptima Neisseria gonorrhoeae Assay receive FDA 510(k) clearance?

Aptima Neisseria gonorrhoeae Assay received FDA 510(k) clearance on 2024-01-26, under 510(k) number K231329.

Who is the listed applicant for Aptima Neisseria gonorrhoeae 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 Neisseria gonorrhoeae Assay?

The FDA product code for Aptima Neisseria gonorrhoeae Assay is LSL.

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Related Devices (Code: LSL)

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.

K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, 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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