The following data is part of a premarket notification filed by Panbio Limited with the FDA for West Nile Virus Igm Capture Elisa, Model E-wnv02m.
| Device ID | K041231 |
| 510k Number | K041231 |
| Device Name: | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M |
| Classification | Elisa, Antibody, West Nile Virus |
| Applicant | PANBIO LIMITED 116 LUTWYCHE RD. Windsor, Brisbane, AU 4030 |
| Contact | Craig Breadmore |
| Correspondent | Craig Breadmore PANBIO LIMITED 116 LUTWYCHE RD. Windsor, Brisbane, AU 4030 |
| Product Code | NOP |
| CFR Regulation Number | 866.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-08-10 |
| Summary: | summary |