FDA 510(k) Application Details - K153223

Device Classification Name	Parainfluenza Multiplex Nucleic Acid Assay   More FDA Info for this Device
510(K) Number	K153223
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	RON DOMINGO 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	11/06/2015
Decision Date	12/09/2015
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
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