FDA.report

510(k) K231316

Device
Aptima Trichomonas vaginalis Assay
Applicant
Hologic, Inc.
510(k) number
K231316
Product code
OUY
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-06
Date received
2023-05-08
Regulation
866.3860
Classification name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jingwen Chen
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-09
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