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510(k) K172282

Device
Panther Fusion Paraflu Assay
Applicant
Hologic, Inc.
510(k) number
K172282
Product code
OOU  
Decision
Substantially Equivalent (SESE)
Decision date
2017-10-23
Date received
2017-07-28
Regulation
866.3980
Classification name
Parainfluenza Multiplex Nucleic Acid Assay
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeffrey Hergesheimer
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
K153223ProParaFlu+ AssayHologic, Inc.2015-12-09
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