The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Respiratory Virus Nucleic Acid Test On The Verigene Sp System.
| Device ID | K093337 |
| 510k Number | K093337 |
| Device Name: | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Gregory Shipp |
| Correspondent | Gregory Shipp NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2009-11-17 |