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510(k) K091053

Device
PROPARAFLU+ASSAY
Applicant
PRODESSE, INC.
510(k) number
K091053
Product code
OOU  
Decision
Substantially Equivalent (SESE)
Decision date
2009-11-20
Date received
2009-04-13
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
KAREN HARRINGTON
Address
W229n1870 Westwood Dr. Waukesha WI US 53186 53186

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
K153223ProParaFlu+ AssayHologic, Inc.2015-12-09
K141927LYRA PARAINFLUENZA VIRUS ASSAYQuidel Corporation2014-10-09
K132238PROPARAFLU+ ASSAYGen-Probe Prodesse, Inc.2013-08-26

Legacy Summary#

summary

FDA Review#

Decision Summary