FDA.reportPublic FDA data

510(k) K191578

Device
ADVIA Centaur Zika Test, ADVIA Centaur Zika Ab (100 Tests), ADVIA Centaur Zika IgM (50 Tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
Applicant
Siemens Healthcare Diagnostics Inc.
510(k) number
K191578
Product code
QFO  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-17
Date received
2019-06-14
Regulation
866.3935
Classification name
Zika Virus Serological Reagents
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthew Gee
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic Systems2020-06-03
K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc.2019-10-28
DEN180069ZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc.2019-05-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases