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510(k) K052519

Device
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
Applicant
SPECTRAL DIAGNOSTICS, INC.
510(k) number
K052519
Product code
NOP  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-30
Date received
2005-09-14
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
NISAR A SHAIKH
Address
135-2 The W. Mall Toronto, Ontario CA M9C 1C2 M9C 1C2

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K041817WEST NILE DETECT IGM ELISAInbios Intl., Inc.2004-11-19
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#

summary

FDA Review#

Decision Summary