510(k) K041231
- Device
- WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
- Applicant
- PANBIO LIMITED
- 510(k) number
- K041231
- Product code
- NOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-10
- Date received
- 2004-05-10
- 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
- CRAIG BREADMORE
- Address
- 116 Lutwyche Rd. Windsor AU 4030 4030
FDA Registration Numbers#
- 3002800697
- 2023365
- 3007361513
- 3003268355
- 2029372
- 2245285
- 3032562
- 2243471
- 3007118747
Source Documents#
Other 510(k) Records For Product Code NOP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | 2016-08-12 |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun Us, Inc. | 2016-08-10 |
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Spectral Diagnostics, Inc. | 2006-11-30 |
| K041817 | WEST NILE DETECT IGM ELISA | Inbios Intl., Inc. | 2004-11-19 |
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | Panbio Limited | 2004-10-20 |
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | Focus Technologies, Inc. | 2004-06-30 |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Focus Technologies, Inc. | 2003-10-22 |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Focus Technologies, Inc. | 2003-10-22 |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | Panbio Limited | 2003-07-08 |
Legacy Summary#
summary
FDA Review#
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