FDA 510(k) Application Details - K243345

Device Classification Name	More FDA Info for this Device
510(K) Number	K243345
Device Name	Aptima BV Assay; Aptima CV/TV Assay
Applicant	Hologic, Inc. 10210 Genetic Center Dr San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Gabriela McCoole Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2024
Decision Date	11/25/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review