The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Cftr Nucleic Acid Test And Verigene Cftr Polyt Nucleic Acid Test.
| Device ID | K083294 |
| 510k Number | K083294 |
| Device Name: | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Gregort W Shipp |
| Correspondent | Gregort W Shipp NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-07-24 |