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510(k) K041817

Device
WEST NILE DETECT IGM ELISA
Applicant
INBIOS INTL., INC.
510(k) number
K041817
Product code
NOP  
Decision
Substantially Equivalent (SESE)
Decision date
2004-11-19
Date received
2004-07-06
Regulation
866.3940
Classification name
Elisa, Antibody, West Nile Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ESTELA I RAYCHAUDHURI
Address
562 1st Ave. S, Suite 600 Seattle WA US 98104 98104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NOP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc.2016-08-12
K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)Euroimmun Us, Inc.2016-08-10
K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTSpectral Diagnostics, Inc.2006-11-30
K041068WEST NILE VIRUS IGG INDIRECT ELISAPanbio Limited2004-10-20
K041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02MPanbio Limited2004-08-10
K040854WEST NILE VIRUS IGM CAPTURE ELISAFocus Technologies, Inc.2004-06-30
K031952WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300MFocus Technologies, Inc.2003-10-22
K031953WEST NILE VIRUS ELISA IGG, MODEL EL0300GFocus Technologies, Inc.2003-10-22
DEN030004WEST NILE VIRUS IGM CAPTURE ELISAPanbio Limited2003-07-08

Legacy Summary#

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FDA Review#

Decision Summary