FDA 510(k) Application Details - K243396

Device Classification Name	More FDA Info for this Device
510(K) Number	K243396
Device Name	Aptima SARS-CoV-2 Assay
Applicant	Hologic, Inc. 10210 Genetic Center Dr. San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Katerina Capkova Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2024
Decision Date	02/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review