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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2024-01-26 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K231329.
When was Aptima Neisseria gonorrhoeae Assay approved by the FDA?
Aptima Neisseria gonorrhoeae Assay received FDA 510(k) clearance on 2024-01-26, under approval number K231329.
What company makes Aptima Neisseria gonorrhoeae Assay?
Aptima Neisseria gonorrhoeae Assay is manufactured by Hologic, Inc..
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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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.