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 (rvnatsp).
| Device ID | K092566 |
| 510k Number | K092566 |
| Device Name: | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Gregory W Shipp |
| Correspondent | Gregory W Shipp NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006409 | K092566 | 000 |
| 00857573006010 | K092566 | 000 |