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FDA 510(k)

Aptima Trichomonas vaginalis Assay

K-Number: K231316 · 2023-11-06

ApplicantHologic, Inc.
Decision Date2023-11-06
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptima Trichomonas vaginalis 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 2023-11-06 under 510(k) number K231316. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima Trichomonas vaginalis Assay?

Aptima Trichomonas vaginalis Assay is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Hologic, Inc.. The 510(k) number is K231316.

When did Aptima Trichomonas vaginalis Assay receive FDA 510(k) clearance?

Aptima Trichomonas vaginalis Assay received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231316.

Who is the listed applicant for Aptima Trichomonas vaginalis 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 Trichomonas vaginalis Assay?

The FDA product code for Aptima Trichomonas vaginalis Assay is OUY.

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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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