FDA 510(k) Application Details - K172282

Device Classification Name	Parainfluenza Multiplex Nucleic Acid Assay   More FDA Info for this Device
510(K) Number	K172282
Device Name	Parainfluenza Multiplex Nucleic Acid 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	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OOU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2017
Decision Date	10/23/2017
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