FDA.reportPublic FDA data

510(k) K141655

Device
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K141655
Product code
OBE  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-05
Date received
2014-06-20
Regulation
866.5100
Classification name
Anti-ss-a 52 Autoantibodies
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GRABRIELLA LAKOS
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBZeus Scientific2026-05-08
K063565QUANTA LITE SS-A 52 ELISAInova Diagnostics, Inc.2007-04-04

Legacy Summary#

summary

FDA Review#

Decision Summary