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510(k) K153223

Device
ProParaFlu+ Assay
Applicant
HOLOGIC, INC.
510(k) number
K153223
Product code
OOU  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-09
Date received
2015-11-06
Regulation
866.3980
Classification name
Parainfluenza Multiplex Nucleic Acid Assay
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RON DOMINGO
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OOU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172282Panther Fusion Paraflu AssayHologic, Inc.2017-10-23
K141927LYRA PARAINFLUENZA VIRUS ASSAYQuidel Corporation2014-10-09
K132238PROPARAFLU+ ASSAYGen-Probe Prodesse, Inc.2013-08-26
K091053PROPARAFLU+ASSAYProdesse, Inc.2009-11-20

Legacy Summary#

summary

FDA Review#

Decision Summary