510(k) K141927

Device: LYRA PARAINFLUENZA VIRUS ASSAY
Applicant: QUIDEL CORPORATION
510(k) number: K141927
Product code: OOU
Decision: Substantially Equivalent (SESE)
Decision date: 2014-10-09
Date received: 2014-07-16
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: Ronald H Lollar
Address: 2005 E. State St., Suite 100 Athens OH US 45701 45701

FDA Registration Numbers#

3008632402
3003030793
3010770794
1650733
2024800
3038610665
3002773840
3006028115
3007799234
1528450
3002777243
3013019728
3006198300

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OOU #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K172282	Panther Fusion Paraflu Assay	Hologic, Inc.	2017-10-23
K153223	ProParaFlu+ Assay	Hologic, Inc.	2015-12-09
K132238	PROPARAFLU+ ASSAY	Gen-Probe Prodesse, Inc.	2013-08-26
K091053	PROPARAFLU+ASSAY	Prodesse, Inc.	2009-11-20

Legacy Summary#

summary

FDA Review#

Decision Summary