Atlas FDA

WEST NILE VIRUS ELISA IGG, MODEL EL0300G

FDA 510(k) clearance K031953 · decided 2003-10-22

Clearance details

K-number
K031953
Device name
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
Applicant
Focus Technologies, Inc.
Decision
Substantially Equivalent
Date received
2003-06-25
Decision date
2003-10-22
Days to decision
119 days
Clearance type
Traditional
Product code
NOP
Device class
2
Regulation number
866.3940
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Cypress, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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EUROIMMUN Anti-West Nile Virus ELISA (IgG) (K153303)Euroimmun Us, Inc.2016-08-10
SPECTRAL WEST NILE VIRUS IGM STATUS TEST (K052519)Spectral Diagnostics, Inc.2006-11-30
WEST NILE DETECT IGM ELISA (K041817)Inbios Intl., Inc.2004-11-19
WEST NILE VIRUS IGG INDIRECT ELISA (K041068)Panbio Limited2004-10-20
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (K041231)Panbio Limited2004-08-10
WEST NILE VIRUS IGM CAPTURE ELISA (K040854)Focus Technologies, Inc.2004-06-30
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952)Focus Technologies, Inc.2003-10-22
WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004)Panbio Limited2003-07-08

Recalls involving this device

RecordFirmDate
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122 recall (Z-0182-2013)Focus Diagnostics Inc2012-10-31