FDA 510(k) Application Details - K190472

Device Classification Name	More FDA Info for this Device
510(K) Number	K190472
Device Name	Aptima CV/TV Assay
Applicant	Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Jeffrey Hergesheimer 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	02/26/2019
Decision Date	05/16/2019
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