FDA 510(k) Application Details - K231316

Device Classification Name	More FDA Info for this Device
510(K) Number	K231316
Device Name	Aptima Trichomonas vaginalis Assay
Applicant	Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Jingwen Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2023
Decision Date	11/06/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review