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510(k) K132238

Device
PROPARAFLU+ ASSAY
Applicant
GEN-PROBE PRODESSE, INC.
510(k) number
K132238
Product code
OOU  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-26
Date received
2013-07-18
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
EMILY ZIEGLER
Address
20925 Crossroads Cir. 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
K091053PROPARAFLU+ASSAYProdesse, Inc.2009-11-20

Legacy Summary#

summary

FDA Review#

Decision Summary