The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral West Nile Virus Igm Status Test.
| Device ID | K052519 |
| 510k Number | K052519 |
| Device Name: | SPECTRAL WEST NILE VIRUS IGM STATUS TEST |
| Classification | Elisa, Antibody, West Nile Virus |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c 1c2 |
| Contact | Nisar A Shaikh |
| Correspondent | Nisar A Shaikh SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c 1c2 |
| Product Code | NOP |
| CFR Regulation Number | 866.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2006-11-30 |
| Summary: | summary |